The Pharma Legal Handbook: Nigeria

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November 2019

1. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs: Nigeria

Key legal info on cannabinoid drugs, medicinal cannabis and opioid drugs in Nigeria. Prepared in association with Olaniwun Ajayi LP, a leading law firm in Nigeria, this is an extract from The Pharma Legal Handbook: Nigeria, available to purchase here for USD 99.

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

Generally, in Nigeria, it is an offence to manufacture, sell, possess, import, export or otherwise deal in cannabinoid drugs without an appropriate license. Cannabinoid drugs may however be used only for medicinal or scientific purposes subject to certain conditions.

2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?

In Nigeria, the regulatory authorities with jurisdiction over cannabinoid drugs are: (i) the National Drug Law Enforcement Agency; and (ii) the National Agency for Food and Drug Administration and Control; (iii) the Federal Ministry of Health; and (iv) the Federal High Court.

The importation, possession, supply, distribution and use of cannabinoid drugs is regulated by the Minister of Health under the Dangerous Drugs Act and the Regulations.

Also, cases of wanton or illegal possession and distribution of cannabinoid drugs in Nigeria are dealt with by the National Drug Law Enforcement Agency (NDLEA).

The National Agency for Food and Drug Administration and Control Agency (NAFDAC) in its capacity as the apex regulatory agency for drug and drug products regulates the manufacture, import, export, advertisement, sale, distribution and use of Medical Cannabis in Nigeria and as such, no cannabinoid drugs can be imported, manufactured, sold or used in Nigeria without the prior approval of NAFDAC.

3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?

While there are no specific guidelines for pricing and reimbursement of cannabinoid drugs, authorization of cannabinoid drugs is regulated by the following statutes: Indian Hemp Act; Dangerous Drugs Act; NDLEA Act, Cap. N30, LFN, 2004; and the NAFDAC Act.

The license to supply, procure, offer to supply or procure, import, export, manufacture or advertise cannabinoid drugs for sale is granted by the Minister of Health of Nigeria and such license must be used in accordance to the terms and conditions attached to it. Also, it is important to note that cannabinoid drugs must be registered with NAFDAC prior to their manufacturing, importation, advertisement, sale or distribution in Nigeria.

4. Which are the cannabinoid drugs that have received market approval to date?

In Nigeria, there is no list of approved cannabinoid drugs. However, given that Indian Hemp, a common cannabinoid drug is legal under Nigerian law for medicinal purposes, it can be inferred that that Indian Hemp is an approved cannabinoid drug for medicinal questions subject to the license granted by Minister of Health.

5. Who can prescribe Cannabinoid Drugs?

Cannabinoid drugs can only be prescribed by medical and dental practitioners and veterinary surgeons.

6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?

There are no list specifying the names or cadre of doctors that can prescribe Cannabinoid drugs in Nigeria. As such, all registered or licensed medical practitioner, registered or licensed dental surgeon or qualified veterinary Surgeons can prescribe cannabinoids drugs.

7. What approvals or notifications are required to prescribe Cannabinoid Drugs?

There are essentially no express provisions for approvals to be sought or notifications to be made to any agency or body, whether prior or subsequent to the prescription of the drugs save for the fact that such prescription must be made by a registered, licensed or qualified Medical and Dental Practitioner, or veterinary surgeon.

In addition to this, The Dangerous Drugs Regulations (“the Regulations”) provides that prescription of these drugs must be in writing, dated and signed by the registered or licensed Medical Practitioner or licensed dental surgeon or qualified veterinary surgeon as the case may be, with his usual signature and address, and shall (x) specify the name and address of the person for whose use the prescription is given; and (y) the total amount of the drug to be supplied on the prescription.

8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?

The Regulations streamlines the category of persons that can distribute this drug. Consequently, only person or organizations licensed by the Minister of Health to either manufacture, import, export or distribute cannabinoid drugs can sell or distribute these drugs.

9. Is there a list of retailers/ distributors authorized to sell Cannabinoid Drugs?

No. As noted above, only persons authorized by the Minister of Health are able to sell or distribute Cannabinoid drugs. There are no known or published lists of these authorized persons.

10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?

Though there are quite a number of pending Bills in the National Assembly on narcotics, from our review of these pending Bills there are no significant change in the licensing or operation of the Cannabinoid drugs regime.

11. When are they likely to come into force?

Given that the bills are still at the preliminary stages, we are unable ascertain with any exactitude when these Bills will come into force.

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

The Indian Hemp Act defines Indian Hemp to include “any plant or part of a plant of the genus cannabis”; the Act goes further to prohibit the planting, cultivation, importation, exportation and use of Indian Hemp in Nigeria. The above provisions and prohibition is however expressed to be subject to the provisions of the Dangerous Drugs Act. The Dangerous Drugs Act authorizes Medicinal Cannabis in Nigeria. This authorization is subject to certain laid down conditions in Nigeria.

13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?

The importation, possession, supply, distribution and use of Medicinal Cannabis is regulated by the Minister of Health under the Dangerous Drugs Act and the Regulations.

Also, cases of wanton or illegal possession and distribution of Cannabis in Nigeria are dealt with by the National Drug Law Enforcement Agency (NDLEA).

The National Agency for Food and Drug Administration and Control Agency (NAFDAC) in its capacity as the apex regulatory agency for drug and drug products regulates the manufacture, import, export, advertisement, sale, distribution and use of Medical Cannabis in Nigeria and as such, no medicinal cannabis can be imported, manufactured, sold or used in Nigeria without the prior approval of NAFDAC.

14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?

While there are no specific guidelines for pricing and reimbursement of medical cannabis in Nigeria, authorization of medical cannabis is regulated by the following statues: Indian Hemp Act; Dangerous Drugs Act; NDLEA Act, Cap. N30, LFN, 2004; and the NAFDAC Act.

The license to supply, procure, offer to supply or procure, import, export, manufacture or advertise medical cannabis for sale is granted by the Minister of Health of Nigeria and such license must be used in accordance to the terms and conditions attached to it. Also, medical cannabis must be registered with NAFDAC prior to its manufacturing, importation, advertisement, sale or distribution in Nigeria.

15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?

Only persons authorized by the Minister of Health are able to produce and import medical cannabis in Nigeria. In the case of imports, an import authorization is required which is granted by the Minister of Health and should specify that medical cannabis can be imported.

16. What approval or notifications are necessary to produce or import Medicinal Cannabis?

The authorization or license to supply, procure, offer to supply or procure, import, export, manufacture or advertise medical cannabis for sale is granted by the Minister of Health of Nigeria.

It is also important to note that such Medical cannabis would be required to be registered with NAFDAC prior to its manufacture or importation in Nigeria.

17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?

Medical Cannabis is regulated by the Indian Hemp Act; Dangerous Drugs Act; NDLEA Act, Cap. N30, LFN, 2004; and the NAFDAC Act.

Its marketing and distribution is subject to the license granted by the Minister of Health.

18. How can patients obtain Medicinal Cannabis?

In Nigeria, further to a prescription by Medical and Dental Practitioners and Veterinary Surgeons, the medical cannabis may be obtained from licensed pharmacists or any other shop for retailing of drugs registered with the Pharmacists Council of Nigeria.

19. Who can prescribe Medicinal Cannabis?

Medical Cannabis can only be prescribed by medical and dental practitioners and veterinary surgeons.

20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?

There are no list specifying the names or cadre of doctors that can prescribe medical cannabis in Nigeria, all registered or licensed medical practitioner, registered or licensed dental surgeon or qualified veterinary Surgeons can prescribe medical cannabis.

21. What approvals or notifications are required to prescribe Medicinal Cannabis?

In addition to this, The Dangerous Drugs Regulations (“the Regulations”) provides that prescription of these drugs must be in writing, dated and signed by the registered or licensed Medical Practitioner registered or licensed dental surgeon or qualified veterinary surgeon as the case may be, with his usual signature and address, and shall (x) specify the name and address of the person for whose use the prescription is given, (y) the total amount of the drug to be supplied on the prescription.

22. Where is Medicinal Cannabis available?

Medical cannabis is available at licensed pharmacists or any other shop for retailing of drugs registered with the Pharmacists Council of Nigeria.

23. Is there a list of retailers authorized to sell Medicinal Cannabis?

No. As noted above, only persons authorized by the Minister of Health are able to sell or distribute medical cannabis. There are no known or published lists of these authorized persons.

24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?

Opioid Drugs

25. Are Opioid Drugs authorized in your country?

In Nigeria, it is an offence to manufacture, sell, possess, import or export or otherwise deal in opioid drugs without an appropriate license. Opioid drugs may however be used for medicinal or scientific purposes subject to certain conditions.

26. What are the regulatory authorities with jurisdiction over Opioid Drugs?

In Nigeria, the regulatory authorities with jurisdiction over opioid drugs are: (i) the National Drug Law Enforcement Agency (NDLEA); and (ii) the National Agency for Food and Drug Administration and Control (NAFDAC); (iii) the Federal Ministry of Health; and (iv) the Federal High Court.

The importation, possession, supply, distribution and use of opioid drugs is regulated by the Minister of Health under the Dangerous Drugs Act and the Regulations.

Also, cases of wanton or illegal possession and distribution of opioid drugs in Nigeria are dealt with by the NDLEA.

NAFDAC in its capacity as the apex regulatory agency for drug and drug products regulates the manufacture, import, export, advertisement, sale, distribution and use of opioid drugs in Nigeria and as such, no medicinal cannabis can be imported, manufactured, sold or used in Nigeria without the prior approval of NAFDAC.

27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?

While there are no specific guidelines for pricing and reimbursement, authorization of opioid drugs is regulated by the following statues: Dangerous Drugs Act; NDLEA Act, Cap. N30, LFN, 2004; and the NAFDAC Act.

The license to supply, procure, offer to supply or procure, import, export, manufacture or advertisement of opioid drugs for sale is granted by the Minister of Health of Nigeria and such license must be used in accordance to the terms and conditions attached to it. Also, cannabinoid drugs must be registered with NAFDAC prior to their manufacturing, importation, advertisement, sale or distribution in Nigeria.

28. Which are the Opioid drugs that have received market approval to date?

An opioid drug that has received market approval in Nigeria is Tramadol. However, only 50mg and 100mg of Tramadol are approved for use in the country.

29. Who can prescribe Opioid Drugs?

Opioid drugs for medicinal purposes can only be prescribed by medical and dental practitioners and veterinary surgeons.

30. Is there a list of doctors authorized to prescribe Opioid Drugs?

There are no list specifying the names or cadre of doctors that can prescribe opioid drugs in Nigeria, all registered or licensed medical practitioner, registered or licensed dental surgeon or qualified veterinary Surgeons can prescribe opioid drugs.

31. What approvals or notifications are required to prescribe Opioid Drugs?

In addition to this, The Dangerous Drugs Regulations (“the Regulations”) provides that prescription of these drugs must be in writing, dated and signed by the registered or licensed Medical Practitioner registered or licensed dental surgeon or qualified veterinary surgeon as the case may be, with his usual sig- nature and address, and shall (x) specify the name and address of the person for whose use the prescription is given, (y) the total amount of the drug to be supplied on the prescription.

32. Which organizations are authorized to sell/distribute Opioid Drugs available?

The Dangerous Drugs Regulations streamline the category of persons that can distribute this drug. Consequently, only person or organizations licensed by the Minister of Health to either manufacture, import, export or distribute opioid drugs can sell or distribute these drugs.

33. Is there a list of retailers/ distributors authorized to sell Opioid Drugs?

No. As noted above, only persons authorized by the Minister of Health are able to sell or distribute opioid drugs. There are no known or published lists of these authorized persons.

34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?

Although there are quite a number of pending Bills in the National Assembly on narcotics, from our review of these pending Bills there are no significant change in the licensing or operation of medical cannabis.

35. When are they likely to come into force?

Given that the bills are still at the preliminary stages, we are unable to ascertain with any exactitude when these Bills will come into force.

Click the following links to read more legal articles from Nigeria:

Also from this Legal Handbook

2. Regulatory Reforms: Nigeria

Regulatory reforms in Nigerian Pharma – a comprehensive legal overview. Prepared in association with Olaniwun Ajayi LP, a leading law firm in Nigeria, this is an extract from The Pharma Legal Handbook: Nigeria, available to purchase here for USD 99.

1. Are there proposals for reform or significant change to the healthcare system?

There are currently various bills before the National Assembly (legislative arm in Nigeria) for the repeal and re-enactment of the extant National Health Insurance Scheme Act, which provides for national health insurance in the country.

The bills are at the preliminary stage in the legislative process, thus its current substance is likely to be revised substantially before enactment.

2. When are they likely to come into force?

Given that the bills are still at the preliminary stages, we are unable to ascertain with exactitude when the bills will come into force. Presently, they have been referred to the Committee of Health within the legislative, for comments and recommendations.

Click the following links to read more legal articles from Nigeria:

Also from this Legal Handbook

3. Patents & Trademarks: Nigeria

Want to know more about patents & trademarks in Nigerian Pharma? Read on! Prepared in association with Olaniwun Ajayi LP, a leading law firm in Nigeria, this is an extract from The Pharma Legal Handbook: Nigeria, available to purchase here for USD 99.

1. What are the basic requirements to obtain patent and trademark protection?

Patents and Trademarks are afforded Intellectual Property (IP) protection under Nigerian law. IP as defined by the World Intellectual Property Organization (WIPO) refers to the creations of the mind: inventions; literary and artistic works; symbols, names and images used in the course of commerce.
Patents are regulated by the Patents and Designs Act 1970, whilst protection of trademarks is regulated by the Trademarks Act Cap T13 LFN 2004 (TMA) and Trademark Regulations 1990.

Patent Protection

Patents are generally exclusive rights over an invention, which provide the patent owner with protection for their inventions.

For an invention to be patentable in Nigeria, such invention must (i) be new; (ii) result from inventive activity; and (iii) be capable of industrial application (Section 1 of the Patent and Designs Act)

The right to registration of a patent is vested in the statutory inventor i.e. the person who, whether or not he is the true inventor, is the first to file an application for the grant of the patent or design. However, where the essential elements of an application for registration and the filing of the application had been obtained without the consent of the true inventor/creator, all rights in the application and any consequent registration shall be deemed transferred to the true inventor/creator. Further, where the statutory inventor/creator files for registration, then the true inventor/creator is entitled to be named as such in the register, and this entitlement may not be modified by contract.

Every application for a patent shall made to the Registrar of Patents and Designs and shall contain the following:

the applicant’s full name and address and, if that address is outside Nigeria, an address for service in Nigeria;
a description of the relevant invention with any appropriate plans and drawings;
a claim or claims;

It shall be accompanied by the following supporting documents:

the prescribed fees;
where appropriate, a declaration signed by the true inventor requesting that he be mentioned as such in the patent and giving his name and address; and
if the application is made by an agent, a signed power of attorney.

Trademark Protection

Section 67 of the TMA defined a trademark as ‘a mark used or proposed to be used in relation to goods for the purpose of indicating, … a connection in the course of trade between the goods and some person having the right either as proprietor or as registered user to use the mark’

The mode of registering a trademark in Nigeria is in writing (S18 of the TMA). For a trademark to be registrable in Nigeria it must contain at least one of the following essential particulars:

the name of a company, individual, or firm, represented in a special or particular manner;
the signature of the applicant for registration or some predecessor in his business;
an invented word or invented words;
a word or words having no direct reference to the character or quality of the goods, and not being according to its ordinary signification a geographical name or a surname;
any other distinctive mark:

The following documents or information are required for the filing an application registration of a trademark:

Power of Attorney (Form 1) – applicable where a trademark agent is submitting the application on behalf of the applicant.
Application for trademark registration Form 2 – This is to be dated and signed by the applicant (s) or his/her duly authorized agent.
Bromides – specimens or exact representation of the marks to be filed.

2. What agencies or bodies regulate patents and trademarks?

Patents and Trademarks are regulated in Nigeria by the Trademarks, Patents And Designs Registry.

3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?

Patents Capable of Protection

In terms of the Patents and Designs Act, Section 1 provides that an “invention” is patentable if

it is new, results from inventive activity and is capable of industrial application; or
it constitutes an improvement upon a patented invention and also is new, results from inventive activity and is capable of industrial application.

It is noteworthy that an invention is capable of industrial application when if it can be manufactured or used in any kind of industry, including agriculture (S2(c) of the Patents and Designs Act.

List of Exclusions from Patentability

Section 4(1) of the Patents and Designs Act expressly provides that patents cannot be validly obtained in respect of the following:

plant or animal varieties, or essentially biological processes for the production of plants or animals (other than microbiological processes and their products); or
inventions the publication or exploitation of which would be contrary to public order or morality (It should be noted that the exploitation of an invention would not be held to be contrary to public order or morality merely because its exploitation is prohibited by law)
principles and discoveries of a scientific nature as they are not inventions for the purposes of the Patent and Designs Act.

Trademarks which can be Protected.

Certain Trademarks can be protected depending on whether or not they adhere to the requirement of distinctiveness. To qualify for registration (and thus protection) under the Trademarks Act, a trademark must be capable of distinguishing the goods or services in relation to which it is used, or proposed to be used, from the same or similar goods or services of others.

A trademark will only fulfil this requirement if, at the date of application for registration it is inherently capable of distinguishing the goods or services in question or if, because of its prior use, it is capable of so distinguishing the goods or services.

4. How can patents and trademarks be revoked?

Grounds for Revocation of Trademarks

Non-use – This situation occurs where the trademark was registered with- out any bona fide intention by the applicant to use same and there has in fact been no bona fide use of the trademark up to one month before the date of the application; or that up to one month before the date of the application, the trademark has not been used for a continuous period of at least five years.
Contravention or failure to observe a condition precedent entered on the register in relation to a trade mark.
Non-renewal: Failure to renew an expired trade mark registration.
Lack of distinctiveness: Where it is alleged that the mark is descriptive or generic and was registered in error, is deceptive, confusing and or misleading.

Grounds for Revocation of a Patent

Revocation can be achieved through an application in the prescribed form on specific grounds only:

where the subject of the patent is not patentable under the requirements of the Patents and Designs Act;
The manner in which the invention is to be carried out by a person skilled to do so, is not fully described, ascertained and illustrated or exemplified (where necessary) in the complete specification of the patent application;
if for the same invention a patent has been granted in Nigeria as the result of a prior application or an application benefiting from an earlier foreign priority.

5. Are foreign patents and trademarks recognized and, if so, under what circumstances?

Trademarks

Section 44 of the Trademarks Act provides that an application may be made in Nigeria, claiming priority on the basis of an earlier mark filed in a Convention country.

The application is made in the same manner as an ordinary application with the certified copies of the earlier trademark application on the basis of which priority is being claimed attached thereto. The Nigerian application must be filed within 6 months of filing the foreign application.

Although the necessary executive order that would specify countries to be recognised in Nigeria as Convention countries in Nigeria is yet to be made, the Trademarks Registry, in practice, accepts applications for foreign priority.

Patents

In cases where a patent application has been filed abroad, Section 27 of Patents and Designs Act provides that the filing date in the country of first filing will provide the applicant or his successor in title, with the right to file a patent application in any number of contracting states within twelve months of the date of filing the first application. The later filed application will enjoy a priority status as if the later filed application had been filed on the same date as the first application.

6. Are there any non-patent/ trademark barriers to competition to protect medicines or devices?

Generally, intellectual property right protection (including patent and trademark) grants the holder the exclusive protection of the creation so that, third parties cannot use the creation without the permission of the creator, usually granted through a license for a fee, with the creator keeping the exclusive rights over the creation. This in itself, exudes monopoly and creates a barrier to competition, as it creates an artificial market limitation or shortage in the market for technology that embodies claims of the patent. Artificial limitations to the market allow the patent owner to raise prices higher than the market clearing price, providing the patent owner with abnormal profits.

Beyond intellectual property protection, Nigerian law does not favour monopoly situations relating to the production or distribution of goods or services of any description within the economy and thus Section 76 of Federal Competition and Consumer Protection Act 2018 (the Act) empowers Federal Competition and Consumer Protection Commission (the Commission) in Nigeria to investigate cases of perceived monopoly. The Commission may refer its findings to the Tribunal established under the Act, which may, on the basis of the Commission’s finding, mete out penalties to entities in deserving instances.

Therefore, in Nigeria, barriers to competition which may be aimed at protecting medicine or medical device are more likely to trigger regulatory intervention.

7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?

List of Exclusions from Patentability

Section 4(1) of the Patents and Designs Act expressly provides that patents cannot be validly obtained in respect of the following:

plant or animal varieties, or essentially biological processes for the production of plants or animals (other than microbiological processes and their products); or
inventions the publication or exploitation of which would be contrary to public order or morality (It should be noted that the exploitation of an invention is not contrary to public order or morality merely because its exploitation is prohibited by law)
Principles and discoveries of a scientific nature as they are not inventions for the purposes of the Patent and Designs Act.

List of Exclusions from Registering of a Trademark

The following cannot be registered as a trademark in Nigeria:

a mark that is not distinctive i.e. it does not meet the requirements stipulated by law regarding distinctiveness
that it is deceptive or scandalous, contrary to law or morality or in any way disentitled to protection;
a mark that contains some prohibited words and/or symbols such as names of chemical substances, use of the Coat of Arms of Nigeria, use of any emblem or title such as President or Governor without the appropriate authority

8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?

A license refers to the relationship between the proprietor of a trademark and the entity authorised by the proprietor to use that trademark in relation to goods manufactured and sold or in respect of the services rendered.

Section 33 of the TMA provides for the registration of any person other than the proprietor of the mark as a registered user in respect of all or any of the goods in respect of which it is registered.

Section 34 of the TMA confirms that an application must be brought by the proprietor and proposed registered user on Form 47 accompanied with a statutory declaration made by the proprietor (or some person authorized to act on his behalf) for the registration of the registered user. The proprietor and registered user may also be required to furnish the Registrar with such further documents, information, or evidence as may be required by the Registrar for the registration.

It can therefore be inferred that a trademark license agreement, whether it is with a foreign licensor or not, may be required by the Registrar for confirmation of approved usage and updating of the of the Registry’s file.

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4. Product Liability: Nigeria

A brief overview of the situation regarding product liability in Nigerian Pharma. Prepared in association with Olaniwun Ajayi LP, a leading law firm in Nigeria, this is an extract from The Pharma Legal Handbook: Nigeria, available to purchase here for USD 99.

1. What types of liability are recognized in your jurisdiction?

In Nigeria, liability may arise from a breach of an obligation implied in law, from a breach of contract in which case a contractual liability will be imposed and from liability in Tort.

Some obligations are imposed by law on manufacturers, suppliers or vendors of products and liability may arise where such persons or organisations breach any of such implied obligations. Such obligation may include an implied warranty of merchantability of the product manufactured or sold. Thus where the product sold turns out to be is defective or unfit for purpose, the manufacturer will automatically become liable to the purchaser or consumer notwithstanding that parties did not enter into an express agreement regarding the merchantability of the product; this is because the law implies and imputes this obligation on the manufacturer or vendor of the product in this regard.

As a corollary to the above, where there is an agreement between the manufacturer, supplier or the consumer as to the quality, efficacy or otherwise of the product either in the form of a representation or by way of a contractual warranty, any of which turns out to be false, untrue or misleading; the manufacturer or such other person may be liable per the terms of such contract, whether such contract is oral or written.

The frontiers of product liability under Torts are not streamlined and liability under this head may be far reaching. Typically, a manufacturer, supplier or vendor may be liable in tort where the receiving party can show that the product purchased was defective or that a damage was caused to the purchaser or consumer whether in terms of personal injury or pecuniary loss.

2. How do these types of liabilities apply to the manufacturers of medicines and devices?

There is currently no law expressly imposing liability on manufacturers of medicines and Medical devices. The Federal Competition and Consumer Protection Act, 2018 (FCCPA) however imposes liabilities on manufacturers, who supply defective or hazardous products or goods to consumers. In this regard, where a manufacturer of medicines or medical devices produces defective or hazardous products which are used by the consumer, such manufacturer may become liable under the FCCPA.

Product liability cannot be restricted or excluded by any contract, either with a supplier, intermediary or the consumer. This liability exists whether or not the consumer bought the goods directly from the manufacturer or entered into any form of contract with the manufacturer of such medical products or devices. Manufacturers would also come under liability where they misrepresent facts which lead to pecuniary loss or health hazards on the part of the consumers. A manufacturer may not restrict or exclude any form of liability which he may be subject to.

3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?

Under FCCPA, contravention of consumer rights attracts criminal liability, both on the part of the manufacturing company and on the part of the Director. The punishment for contravention on a Director of a company found liable is a term of imprisonment not exceeding five (5) years or to a fine of Ten Million Naira (N10,000,000) or a combination of both. Suppliers of the product if found liable are also subject to the same punishment.

4. How can a liability claim be brought?

Aggrieved consumers seeking to enforce any of the rights under the FCCPA may refer the matter to the business/undertaking or to the applicable industry sector; file a complaint directly with the Federal Competition and Consumer Protection Commission or directly approach a court of competent jurisdiction. Notably, consumers aggrieved by a breach of their rights under the Act may have recourse to Civil Society Groups who are also empowered to grant redress to victims of defective goods and/or services.

Where a consumer or such other person do not hinge their claim on the FCCPA, recourse will only be had to the Court.

5. What defences are available?

The nature of defence which may be available to a defendant in an action or claim arising from a product is unique to the product liability action. Prominently, a manufacturer, producer or any person against whom an action is brought may plead in his defence that the injury to the Claimant was not caused by the product; or that there was contributory negligence on the part of the Claimant (where a claim under Tort is brought). A defence of contributory negligence will however not totally absolve the manufacturer or supplier of complete liability on the claim.

A defence that the action is caught by the Statute of Limitation can also be available where being an action founded in simple contract, it is instituted after six (6) years from the date the cause of action arose or in the case of damages arising from negligence [where damages consist of or include personal injury] is instituted after three years of the date the cause of action accrued.

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5. Traditional Medicines and OTC Products: Nigeria

The low-down on the situation regarding traditional medicines and OTC products in Nigerian Pharma. Prepared in association with Olaniwun Ajayi LP, a leading law firm in Nigeria, this is an extract from The Pharma Legal Handbook: Nigeria, available to purchase here for USD 99.

1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?

Herbal medicines and related products are products that contain exclusively active ingredients of one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations presenting with therapeutic and prophylactic claims.

Traditional, Herbal, Complementary and alternative medicines and devices must be registered with NAFDAC before they can be imported, used, sold, manufactured or advertised in Nigeria.

Advertisements for complementary and alternative medicine are also not to state or imply in absolute terms or by quotation out of context, that any complementary and alternative medicine is “safe” or has “guaranteed efficacy” or special status. Nor contain any statement claiming or implying a superlative function such as “most effective” “least toxic, “best tolerated” or other special status.

The label of complementary and alternative medicine is to specify conspicuously in the information panel the name and full location address of the factory of the manufacturer or packer; a quantitative list of ingredients of the complementary and alternative medicine by their botanical names or, by their common names, are also to be declared quantitatively on the advertisement label.

Products should be handled and transported under conditions which prevent deterioration, contamination, spoilage and breakage to ensure that the product quality is maintained up to the time of delivery to the consumer while the devices are to conform with the standards of Good Manufacturing Practice (GMP).

2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?

The Complementary and Alternative Medicine (Advertisement) Regulations 2018 regulates the advertisement of traditional, herbal, complimentary or alternative products, the Regulations allows for direct public advertisement of these products provided

they have been registered with NAFDAC,
the advertisement has the approval of NAFDAC,
they are not extemporaneous complementary or alternative medicine
such advertisement does not relate to complementary or alternative medicine as a cure, prevention, treatment for any disease conditions listed in Schedule 1 or as may be prescribed by the Agency

NAFDAC by the Regulations also require that the advertisement of such medicine must be accurate, complete, clear and designed to promote credibility and trust by the general public and health care practitioners, as such statements or illustrations in labelling or advertisement shall not mislead the public directly, indirectly or by implication. Cautionary label or disclaimer statement must be displayed on the label and advertisement materials of complementary and alternative medicine.

3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?

The Drug and Drug Products Advertisement Regulations define a claim to mean any presentation, which states, suggests or implies that the product has particular qualities relating to its origin, nutritional properties, nature, processing, composition or any other quality.

Claims can be made for traditional, herbal, complementary and alternative products except as expressly prohibited by NAFDAC. The Regulation proscribes the inclusion of certain claims in the advertisement or marketing of these products and as such no complementary and alternative medicine advertisement shall in addition to other restrictions contained in the Regulation:

contain such word as “magic” “miracle’’ or an exotic description such as “upper potency” or such other words as to induce the daily or continuous use of the product;
contain a message that if the reader/viewer or listener does not use a particular product his disease/ailment shall be aggravated;
over dramatize any symptoms by way of drawing a picture of a pregnant woman, patient with backache, or use throbbing sounds like heartbeats, coughing or agonizing cries;
disparage or attack unfairly, any competitive products, goods or services.

Also, all herbal products (without established clinical studies) label and advert documents must include a caveat that the claims contained in the packaging or labelling document has not been evaluated by NAFDAC.

4. What are the regulatory requirements for over-the- counter (non-prescription) medications?

The provisions of the Drug and Drugs Products (Registration) Regulations 2018 serve as regulatory framework for non-prescription medications. The Regulation provides certain conditions which a product must satisfy in order to qualify as Over-the-Counter (OTC) Medicine. A foreign drug product may be registered as an OTC on the basis of its OTC status from its country of origin if it has been marketed as an OTC for a minimum of 5 continuous years in the country of origin and in sufficient quantity, or subject to other requirements as may be prescribed by NAFDAC.

NAFDAC will not register a product as an over –the-counter drug product unless; (x) it is demonstrated that there is an established efficacy and safety of use among the relevant population (y) there is no specific safety concern limiting its safe use without medical assistance (z) indication for its use is easily diagnosable or self-limiting as the case may be (xx) pack presentation is tailored to the approved duration and indication of use.

5. Are there any limitations on locations or channels through which OTC products may be sold?

No, In so far as OTC products are sold by in premises owned by Pharmacists and the patent and proprietary medicines vendors licensees licensed under the Pharmacists Council of Nigerian Act.

6. What health, advertising, and marketing claims may be made for OTC products?

Claims in relation to OTC drugs are representation, which suggests or implies that the product has particular qualities relating to its origin, nutritional properties, nature, processing, composition or any other quality”

All Claims except those expressly prohibited by NAFDAC in the Drug and Drug Products Regulations can be made in relation to OTC drugs. Such claims regarding words such as “magic” “miracle’’ are prohibited.

The Regulation also prohibits claims which:

contain a message that if the reader/viewer or listener does not use a particular product his disease/ailment shall be aggravated;
over dramatize any symptoms by way of drawing a picture of a pregnant woman, patient with backache, or use throbbing sounds like heartbeats, coughing or agonizing cries;
disparage or attack unfairly, any competitive products, goods or services.

In addition, Over-the-Counter (OTC) drugs are to include the Caveat “If Symptoms Persist after 3 Days, Consult Your Doctor/Physician”.

7. Can OTC products be marketed or advertised directly to the public?

Where an over the Counter Drug is duly registered with NAFDAC, it can be marketed and advertised directly to the public, provided also that both the brand name and the generic name of such drugs are boldly stated on it.

8. What is the mechanism by which a prescription-only product can be converted to an OTC product?

There are currently no laid down mechanism for product switch from Prescription only medicine to Over-the-Counter drug, however, by the Drug and Drug Product Regulation 2018; a conversion or switch from prescription only product to OTC is prohibited except approved by NAFDAC.

There are however no modalities or laid down rules indicative of the conditions, ratios, or factors which NAFDAC may consider in denying or granting approval for the conversion.

9. What are the requirements for the importation of either traditional medicines or OTC products?

Where it is demonstrated that (x) there is an established efficacy and safety of use among the relevant population (y) there is no specific safety concern limiting its safe use without medical assistance (z) indication for its use is easily diagnosable or self-limiting as the case may be (xx) pack presentation is tailored to the approved duration and indication of use then these products may be imported into Nigeria.

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6. Marketing, Manufacturing, Packaging & Labeling, Advertising: Nigeria

The legal framework for marketing, manufacturing, packaging & labeling, advertising in Nigerian Pharma. Prepared in association with Olaniwun Ajayi LP, a leading law firm in Nigeria, this is an extract from The Pharma Legal Handbook: Nigeria, available to purchase here for USD 99.

1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?

NAFDAC is the body responsible for regulating and controlling the manufacture, importation, exportation, advertisement, distribution, sale and use of food, drugs, biologics, medical devices, chemicals and other medicinal product in Nigeria. Consequently, none of the foregoing items, whether locally produced or imported is to be used, marketed or advertised in Nigeria without prior registration with NAFDAC.

The Guidelines for Advertisement of NAFDAC Regulated Products in Nigeria (The Guidelines), is the principal enactment governing the advertisement and marketing of regulated products in Nigeria.

In terms of the guidelines, registration of a product or item with NAFDAC does not automatically confer an advertising permit. A separate application and subsequent approval by NAFDAC shall be required if the product is to be advertised. For purposes of effective management of time, the guidelines allow a simultaneous submission of registration and advertisement applications to NAFDAC.

In advertising pursuant to the regulation, the following restrictions are operative under the NAFDAC Regulations:

Consumer promotions are not allowed for medicinal products.
Prescription-Only-medicines (POM) may be advertised only in Medical/ Scientific Journals and such advertisement materials must contain abridged prescribing information including composition, indication, dosage, administration, adverse effects, drug interactions, contraindications, warnings and precautions.
All herbal medicinal products (without established clinical studies) and advert materials shall include the caveat, “These claims have not been evaluated by NAFDAC”
Advertisements of Over-the-Counter (over) drugs are to include the Caveat “If Symptoms Persist after 3 Days, Consult Your Doctor/Physician”.
A vetting approval would also have to be obtained from the Advertising Standards Panel (ASP), a statutory committee of the Advertising Practitioners Council of Nigeria (APCON), where the manufacturer intends to advertise its products in Nigeria.

2. What is the authorization process for the marketing of generic versions of these products?

The authorization process for the marketing of the generic versions of new drugs, biologics, medical devices, over the Counter medications and other medical products is the same as above. Generic versions of these drugs do not require a different process for its marketing as this can be done through a single application process.

3. What are the typical fees for marketing approval?

The fees chargeable by NAFDAC for an application for advert approval are set out in the Guidelines. The fees typically is ₦10,000 (Ten Thousand Naira) per product, per medium, per concept, per language while the cost of renewal is at ₦6,000 (Six Thousand Naira) per product, per medium, per concept, per language. These fees are subject to VAT at 5%.

4. What is the period of authorization and the renewal process?

The Guidelines provides that the timeline for the processing of an application for advertisement or marketing is 20 working days.

All adverts when approved are valid for one year from the date of the approval. Although the process for renewal of an advert license is not stipulated in the Guidelines, in practice, all the prior documents submitted for the grant of the initial approval in addition with the evidence of initial approval are the documents to be submitted to NAFDAC for the renewal of the approval. This is usually carried out before the expiration of the existing approval.

5. What are the requirements, if any, for post-approval pharmacovigilance?

The NAFDAC Good Pharmacovigilance Practice Guidelines 2016 prescribes several compliance requirements for the holder of a product marketing approval. These prescriptions are primary for the solving and reconciliation of any development on the approved product that may impugn on the potency or other aspects of the products.

NAFDAC requires an efficient risk management of the medicinal products by the holder of the marketing license. This is achieved by a production of a Risk Management Plan (RMP) as provided by the 2016 Guidelines. A RMP requires the input of different specialists and departments within and/or outside an organization; typically, the safety specification may require involvement of toxicologists, pharmacoepidemiologists, clinical pharmacologists, clinical research physicians and pharmacovigilance experts. The input required for the pharmacovigilance plan may require any of these experts depending upon the safety concerns identified in the safety specification and the types of activities planned to address them.

Since a risk management plan is primarily a pharmacovigilance document, ideally the production of it should be managed by personnel with appropriate pharmacovigilance training. Regardless of who prepares the RMP, the responsibility for the content and accuracy of the RMP remains with the marketing authorisation applicant/holder who should ensure oversight by someone with the appropriate scientific background within the company:

The RMP consists of seven parts:

The product(s) overview
Safety specification
Pharmacovigilance plan
Plans for post-authorisation efficacy studies
Risk minimisation measures (including evaluation of the effectiveness of risk minimisation measures)
Summary of the risk management plan
Annexes

A holder/applicant of a marketing approval as a step in pharmacovigilance is responsible for: ensuring that it constantly monitors the risks of its medicinal products and reports the results of this, as required, to NAFDAC; while taking all appropriate actions to minimise the risks of the medicinal product and maximise the benefits including ensuring the accuracy of all information produced in relation to its medicinal products, and actively updating and promptly communicating when new information becomes available.

6. Are foreign marketing authorizations recognized?

Foreign marketing authorizations in so far they relate to advertisements are not recognized. Drugs, drugs products and or medical devices whether or not it has an advertisement license or approval in other jurisdictions are still subject to the application requirements before an advert approval by NAFDAC for such products or device can be advertised or marketed in Nigeria. Also, Drugs that have been registered in foreign jurisdictions will nonetheless mandatorily have to be registered in Nigeria with NAFDAC in line with the Food and Drugs Act and other Regulations before they can be imported, sold, distributed or used in Nigeria.

7. Are parallel imports of medicines or devices allowed?

There exist no particular law which favours a recognition of parallel imports of medicines, drugs, or devices in Nigeria.

However as has already been highlighted in the preceding chapters, there is a restriction on the importation of any drug into Nigeria without the prior approval of NAFDAC, such consent or approval by NAFDAC takes the form of registration of the drugs to be imported. For such approval for importation to be granted to a potential importer of drugs or devices by NAFDAC, the Agency as one of its mandatory requirements requires that evidence of the written consent and or authority of the manufacturer of the product to such importer must be presented to NAFDAC where any other person or entity other than the manufacturer makes an application for the registration. Such authorization is usually in the form of a power of Attorney which is issued by the manufacturer of the drugs or medical device and must state the names of the products to be registered, the ownership of brand names and trademarks registered in Nigeria.

Also, in the Trade Marks Act, Section 5 (2) of the Act confers on the owner of the registered mark, the exclusive right to use the trade mark in marketing or selling his goods. The Act also confers on the registered owner of the trade mark the right to initiate an action to seek redress for infringement of his trade mark if a person not being a permitted user of the trademark uses the mark in relation to any goods in respect of which the trademark is registered.

The above provisions thus unwittingly prohibit and disallows the parallel import of medicines or devices in Nigeria which has as its chief trait the absence of consent or knowledge of such importation on the part of the registered owner of the trademark.

8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?

In Nigeria, the Medical and Dental Practitioners Act together with the Code of Medical Ethics are the chief laws regulating the conduct of medical practitioners in Nigeria. These bodies of laws also regulate the practice of medicine in different healthcare centers.

Both the Code and the Act do not make provision for the regulation of the nature, manner of involvement or restriction of a medical practitioner in marketing or promotional activities of drugs or drug products. It is thus not unusual to see medical practitioners being entertained at events hosted by drug manufacturers or being handed customized gifts in such events.

9. How is the manufacturing of medicines and devices regulated and by which agencies?

NAFDAC has the sole responsibility for the regulation of the manufacture of Medicines and related products, this power is conferred on it by the provisions of the Food Drugs and Related Products (Registration, Etc) Act, and several Guidelines and Regulations made pursuant to the Act.

NAFDAC exercises its power of control and regulation by approving all manufacture of medicines and related products before they can be passed on to the consumer for consumption or use. NAFDAC, backed by the provisions of the Good manufacturing practice Guidelines for Pharmaceutical products 2016 regulates the manufacture of these products by ensuring that the following essential elements are in existence and all necessary facilities for GMP are provided including:

Appropriately qualified and trained personnel;
Adequate premises and space;
Suitable equipment and services;
Appropriate materials, containers and labels;
Approved procedures and instructions;
Suitable storage and transport;
Adequate personnel, laboratories and equipment for in-process controls;

In a nutshell, Paragraph 1.2 of the Guidelines for pre-registration Inspection of Pharmaceutical Manufacturing Facilities in Nigeria provides that “drug product should not be manufactured in Nigeria unless the facility has been inspected, found to comply with Good Manufacturing Practices and an Authority to Manufacture pharmaceutical products is issued by NAFDAC”.

10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the US Food & Drug Administration (US FDA) and/or the European Medicines Agency (EMA)?

Good Manufacturing Practices in Nigeria are regulated by NAFDAC pursuant to which it has issued the Good Manufacturing Practice Guidelines for Pharmaceutical Products. The Guidelines has robust provisions stipulating the minimum standards manufacturers are required to adhere to in order to ensure the quality of pharmaceutical products in the country. It also provides for: good manufacturing practice requirements; for methods, facilities and controls for the manufacture, processing, packaging or holding of a pharmaceutical product for human or animal use; and self-inspection.

In light of this, we are of the view that our local requirements are fairly compatible with good manufacturing practices defined by the U.S. Food & Drug Administration and European Medicines Agency. This is evident in the Guidelines issued by NAFDAC in this regard, which provide for similar provisions to these jurisdictions such as quality system and control, self-inspection by the manufacturing company at least once a year, etc.

11. What is the inspection regime for manufacturing facilities?

The NAFDAC Guidelines for Pre-Production inspection of Pharmaceutical Manufacturing Facilities in Nigeria provides that drug products should not be manufactured in Nigeria unless the facilities where they are to be manufactured have been inspected, found to comply with Good Manufacturing Practices and an Authority to Manufacture pharmaceutical products has been issued by NAFDAC.

The guidelines also prescribe the minimum requirements necessary for the issuance of an Authority to Manufacture Pharmaceutical products. The relevant guidelines are available on the NAFDAC website.

An application for Pre-Production Inspection should be made on the company’s letter-headed to The Director, Drug Evaluation & Research Directorate; with (i) Site Master File of the proposed facility; (ii) evidence of company incorporation; (iii) evidence of License to Practice of the Superintendent and Production Pharmacists by the Pharmacists Council of Nigeria (PCN); (iv) Company Quality Manual; and (v) validation Master Plan for the facility.

In addition to the above, self-inspection is included in NAFDAC’s Guidelines on Good Manufacturing Practice (GMP), whereby it is indicated that self-inspection must be conducted in order to monitor the implementation and compliance with GMP principles and to recommend necessary corrective actions. All self-inspections should be conducted in an independent and detailed manner by designated competent persons from the manufacturing company. It is provided that there must be at least one self-inspection in a year.

12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?

This is currently not provided in the relevant guidelines or laws regulating the manufacturing in the pharmaceutical industry. Instead, what is envisaged is an inspection carried out by NAFDAC.

However, given that the relevant laws do not provide for an express restriction on approaching NAFDAC with a request for such allowance, a request may be made by a third-party or foreign inspection in this regard.

13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?

The objectives of drug storage are to ensure stock security and the maintenance of the quality of drugs throughout their shelf life. The efficient and successful operation of a drug storage and distribution system requires the professional skills of pharmacists. Therefore, pharmacists are charged with the responsibility of overseeing the drug stores operated by federal, state and local governments as well as in the private sector.

It is expected that public and private sector establishments put adequate mechanisms in place to ensure that the temperature in all drug storage facilities is maintained at not more than 20oC for the sustenance of the shelf life of drugs. In respect of vaccines and biological products, pharmacists are expected to provide appropriate cold storage for the maintenance of the shelf life of such vaccines and products. Also, regular checks on the quality of stored drugs shall be undertaken to ensure that they do not deteriorate under storage conditions.

14. What information must be included in medicine and device labeling?

There are several specific requirements in relation to what must be included in labels of medicines and medical devices. It important to note that before a product can be registered with NAFDAC, it must have first approved the label or artwork of the product.

Labelling is regulated by the relevant NAFDAC guidelines for the registration of medicine or medical device. The following are the applicable labelling guidelines for drugs in Nigeria:

the labeling should be informative and accurate.
minimum requirements on the label are as follows:

➢ Name of product (brand name) where applicable and generic name.
➢ Name and full location address of the manufacturer.
➢ Provision for NAFDAC Registration Number on product label
➢ Batch No., Manufacturing date and Expiry date.
➢ Dosage form & strength
➢ Indications, frequency, route, conditions of administration (for OTC drugs).
➢ Dosage regimen on the package (for OTC drugs).
➢ Patient Information Leaflet (PIL)
➢ Prescribing information (for prescription only medications).
➢ Net content of product
➢ Quantitative listing of all the active ingredients per unit dose
➢ Adequate warnings where necessary.
➢ Where a brand name is used, there must be the generic name which should be conspicuous in character, written directly under the brand name.

Also, it is important to note that drug products whose name or package label bear close resemblance to an already registered product or is likely to be mistaken for such registered product, shall not be considered for registration. Further, any drug product which is labelled in a foreign language shall not be considered for registration by NAFDAC unless an English translation is included on the label and patient leaflet information (where applicable).

15. What additional information may be included in labeling and packaging?

In addition to the above requirements, medicines in containers of less than or equal to 10 ml capacity that are marketed in an outer pack such as a carton, and the outer pack bears all the required information, the immediate container need only contain:

Name of the finished pharmaceutical product (i.e. (invented) name, strength, pharmaceutical form), active substance(s) and route(s) of administration.
Route of administration
Manufacturing Date
Expiry date
Batch number
Contents by weight, by volume or by unit
The name and address of the supplier (i.e. the manufacturer) if space permits otherwise the name of the manufacturer should be stated or a logo that unambiguously identifies the company.
Directions for use, and any warnings or precautions that may be necessary.

16. What items may not be included in labeling and packaging?

Labelling and packaging link directly with the marketing of a product and in terms of Clause 5.2 of the Guidelines for Advertisement of NAFDAC Regulated Products in Nigeria, the labeling of all products must comply with the labelling requirement as registered. This implies that the label and package of the regulated product (which include medicines and medical devices) must not include any information that is in contravention of the information which was included in the original application to NAFDAC when the application for registration of the product was made.

17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?

The starting point is that there is a requirement to obtain an advertisement approval from NAFDAC before any medicine or medical device can be marketed and advertised in Nigeria. The following are the applicable restriction on advertising of medicines and medical devices in Nigeria:

Consumer promotions are not allowed for medicinal products. For medical devices on the other hand, consumer promotions are valid for only fifteen (15) weeks.
Prescription-Only-medicines (POM) may be advertised only in Medical/ Scientific Journals.
Advertisement materials for Prescription-only-Medicines (POM) must contain abridged prescribing information including composition, indication, dosage, administration, adverse effects, drug interactions, contraindications, warnings and precautions.
Advertisement of Over-the-Counter (OTC) drugs are to include the Caveat “If Symptoms Persist after 3 Days, Consult Your Doctor/Physician”.
All herbal medicinal products (without established clinical studies) and advert materials shall include the caveat, “These claims have not been evaluated by NAFDAC”.
Section 2 of the Food and Drugs Act 1976 prohibits advertisements of drugs or device represented as treatment, preventive or cure for any of the diseases or disorders specified in the First Schedule to the Food and Drugs Act. The First Schedule of the Act contains a list of about sixty-five diseases and disorders and it includes alcoholism, cancer, obesity, sleeping sickness, acquired immune deficiency syndrome, diabetes, etc.
Section 5 of the Food and Drugs Act prohibits advertisement of a drug in any manner that is false or misleading or is likely to create a wrong impression as to its quality, character, value, quality or safety.

In addition to obtaining an advertisement approval from NAFDAC, the manufacturer would be required to obtain a vetting approval from the Advertising Standards Panel (ASP), a statutory committee of the Advertising Practitioners Council of Nigeria (APCON). APCON was established by the APCON Act of 1988 and it is charged with the responsibility of regulating and controlling the practice of advertising in Nigeria.

Therefore, approval from both NAFDAC and APCON are required for the advertisement of medicines and medical devices in Nigeria.

18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?

Medicines can be sold and delivered by licensed pharmacists registered with the Pharmacists Council of Nigeria (Pharmacist Council) at pharmaceutical premises duly registered with Pharmacists Council. Although the medicines are to be sold at the registered pharmaceutical premises, delivery may however be effected via post or any other means.

It is important to note that there are no express legal restrictions relating to delivery of medicines via post provided the sale was carried out at a registered pharmaceutical premises.

19. What are the restrictions and requirements for electronic marketing and advertising via email, by internet, social media, and other channels?

Electronic marketing or advertisement via email, internet etc. are allowed in Nigeria subject to obtaining an advertisement approval from NAFDAC and a vetting approval from APCON.

To obtain advertisement approval from NAFDAC, the following documentation would be required:

an application in writing on the applicant’s letter head addressed to the Director General of NAFDAC;
duly completed prescribed application form;
two copies of the receipt of purchase of the form;
evidence of product registration with NAFDAC;
a letter of introduction of Advert Agent from the applicant (where applicable); and
telephone no. and email address of the directors of the applicant/Advert Agent.

The applicant would also be required to submit a script where the advertisement is to be aired online. The timeline for obtaining the advertisement approval is approximately twenty (20) working days from the date the application is submitted to NAFDAC.

20. May medicines and devices be advertised or sold directly to consumers?

Certain medicines and devices are prohibited from advertisements in Nigeria. Section 2 of the Food and Drugs Act 1976 prohibits advertisements of drugs or device represented as treatment, preventive or cure for any of the diseases or disorders specified in the First Schedule to the Food and Drugs Act. The First Schedule of the act contains a list of about sixty-five diseases and disorders and it includes alcoholism, cancer, obesity, sleeping sickness, acquired immune deficiency syndrome, diabetes, etc.

Medicines not covered by the above prohibition may however be advertised directly to consumers.

In relation to direct sale to consumers, there is no express prohibition in Nigeria on the sale of medicines and medical devices to consumers directly. Thus, it may be inferred that medicines and medical devices may be sold directly to consumers.

21. How is compliance monitored?

Compliance is monitored by the Investigation and Enforcement Directorate of NAFDAC. This directorate is responsible for ensuring compliance with NAFDAC’s mandate on regulatory activities. It receives and investigates complaints.

In addition to monitoring carried out by NAFDAC, APCON also has a Monitoring Unit which utilizes the services of media monitoring agencies. Also, members of APCON provide backup monitoring information to ensure that manufacturers conform to the provisions of the APCON vetting guidelines and other laws relating to advertising. Members of the public also monitor and report cases of unwholesome advertisements to APCON through ad-check numbers and e-mails.

22. What are the potential penalties for noncompliance?

Penalty imposed by NAFDAC

Failure to obtain advertisement approval from NAFDAC where a regulated product is to be advertised will make the manufacturer liable to sanctions. Also, where the failure is proved to have been committed with the consent or connivance of, or to be attributable to any neglect on the part of any director, manager, secretary or other similar officer of manufacturing company or any person purporting to act in any of those capacities, he, as well the company shall be deemed to be guilty of the offence and shall be liable on conviction to a fine of ₦100,000 (One Hundred Thousand Naira).

Penalty imposed by APCON

Failure to obtain vetting approval from APCON before exposure of the advertisement, will attract a minimum penalty of ₦500,000 (Five Hundred Thousand Naira).

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7. Preclinical and Clinical Trial Requirements: Nigeria

All legal aspects surrounding preclinical and clinical trial requirements in Nigerian Pharma. Prepared in association with Olaniwun Ajayi LP, a leading law firm in Nigeria, this is an extract from The Pharma Legal Handbook: Nigeria, available to purchase here for USD 99.

1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?

Clinical trials are not required in all cases, clinical trials will be required to be conducted as a condition for marketing approval where there is a clear uncertainty of the efficacy of the test drug in the Nigerian population. It is considered unethical to continue to conduct clinical trials for a drug whose efficacy has been clearly established especially where there is no scientific reason to believe that available results cannot be generalised.

Thus, foreign drugs are subjected to clinical trials if the drugs do not have adequate and well documented use in black population or it has some race specific properties or its efficacy, safety and usefulness needs to be proven in the population.

Essentially, by the Food, Drugs And Related Products (Registration, Etc.) Act, a clinical trial is mandatory for the following:

New or relatively new chemical entities or herbal formulations for which safety/efficacy profile has not been determined.
Drugs for new indications.
Drugs for new patient population group e.g. Age group and race.
New combination drug products.
New dosage schedule/regimen.
New drug delivery system
Academic clinical trials.

2. How are clinical trials funded?

Clinical trials are initiated and funded by sponsors who promote clinical study, testing or studying of a drug or medical device to ascertain its safety and effectiveness. The Good Clinical Practice Regulations 2009 defines a sponsor as “an individual, company, institution or organization which takes responsibility for the initiation, management and/or financing of a clinical trial” Clinical trials could be “industry sponsored” or “investigator initiated”.

In Nigeria, clinical trials are often funded by the sponsor pharmaceutical companies, academic medical centers, voluntary groups and international non-governmental agencies and other organizations whose main objective is to ensure that the clinical trials are successfully carried.

3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?

A key requirement of preclinical and clinical trial protocols is the presence of informed consent. Informed consent involves two essential components: a document and a process. The informed consent document gives a summary of the research project (including the study’s purpose, research procedures, potential benefits and risks, etc.) and explains the individual’s rights as a research participant. This document is part of an informed consent process, which consists of conversations between the research team and the participant, and may include other supporting material such as study brochures. The informed consent process provides research participants with ongoing explanations that will help them make informed decisions about whether to begin or continue participating in the research project.

Preclinical and clinical protocols like most clinical studies are based on a set of rules or directions. The protocol would often describe what types of people are eligible to participate in the study; the schedule of tests, procedures, medications and dosages and the length of the study.

There is no particular legislation which prescribes the contents of pre-clinical or preclinical protocols in Nigeria, however these protocols may contain the following basic and fundamental requirements:

Background information
Trial Summary
Background to the Trial
Aim, Hypothesis and Outcome of the Trial.
Trial Design
Eligibility Criteria for participants
Informed Consent
Safety considerations
Study Overview
Quality control and Assurance
Ethical considerations
Sponsor (funding)
Insurance and Indemnity
Financial Support

Two regulatory authorities are responsible for the grant of approval of the protocols: the National Agency for Food and Drug Administration and Control (NAFDAC) and the National Health Research Ethics Committee (NHREC) (acting through Independent Ethics Committees (IEC)). Initial approval of the protocols are done by the Independent Ethics Committees (IEC) accredited by the National Health Research Ethics Committee (NHREC) which body gives ethical opinion on study protocols to NAFDAC depending on the number of trial sites involved.

Ethical clearance is granted by the IEC on the protocol, the initial approval or opinion on the protocols is granted by NHREC and the final approval is granted by the National Agency for Food and Drug Administration and Control (NAFDAC) in terms of the Food, Drugs And Related Products (Registration, Etc.) Act.

In order to reduce processing timeline for Clinical Trial applications, the study protocol can be submitted simultaneously to NAFDAC and the Ethics Committee.

4. What are the requirements for consent by participants in clinical trials?

In Nigeria, this is unarguably essential in the ethical conduct of research in general and clinical trials in particular. The Good Clinical Practice Regulations defines informed consent as the “Decision, which must be written, dated and signed, to take part in a clinical trial, taken freely after being duly informed of its nature, significance, implications and risks and appropriately documented, by any person capable of giving consent or, where the person is not capable of giving consent, by his or her legal representative; if the person concerned is unable to write, oral consent in the presence of at least one witness may be given in exceptional cases”.

Potential subjects should thus be informed of the objectives and methods of the study, the drug product and treatment regimen, the available alternative treatments, potential risks and benefits, and of possible complications and discomforts, which may arise from participation in the study.

Based on information received and understood, the potential subject freely gives consent to participate in a study, this is known as informed consent. This consent should not be obtained through inducement or coercion and the subject should be aware that he/she may withdraw from the study at any time, and this will not affect his/her future medical care in any way; thus consent can only be sought under circumstances that provide the prospective participant or the representative sufficient opportunity to consider whether or not to participate and the circumstances shall minimize the possibility of coercion or undue influence.

The NHREC has made recommendations on the contents of the informed content document and process. The informed consent document should contain the following aspects:

Title of the research
Name(s) and affiliation(s) of researcher(s) of applicant(s)
Sponsor(s) of research
Purpose(s) of research
Procedure of the research, what shall be required of each participant and approximate total number of participants that would be involved in the research.
Expected duration of research and of participant(s)’ involvement.
Risk(s)
Costs to the participants, if any, of joining the research
Benefit(s)
Confidentiality
Voluntariness
Alternatives to participation
Incentive (inducement) to participants
Consequences of participants’ decision to withdraw from research and procedure for orderly termination of participation.
Modality of providing treatments and action(s) to be taken in case of injury or adverse event(s).
What happens to research participants and communities when the research is over?
Statement about sharing of benefits among researchers and whether this includes or exclude research participants.
Any apparent or potential conflict of interest.
Detailed contact information including contact address, telephone, fax, e-mail and any other contact information of researcher(s), institutional HREC and head of the institution.

All consent process must be documented and in circumstances where participants are unable to provide signed consent, other alternatives such as thumb printing and witnessed audio recording may be carried out.

Where the investigator fails to obtain informed consent of participants, this may raise grievous ethical questions which may lead to actions against the investigator. The Pfizer Trovan 1996 case gives credence to this.

5. May participants in clinical trials be compensated?

Indeed. while there are no specific provisions regarding the manner, amount and method of compensation, most studies offer monetary compensations to participants for the time they spent participating in a trial, this amount is given to cover expenses for transportation, meals, and possibly, for lost work time; payment may however not be substantial enough to constitute inducement to participate for monetary gain.

Aside from the above and as a way of alternative compensation, sponsors, researchers and investigators may make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This is often crucial in novel breakthrough drugs for life threatening or terminal conditions especially as participants are usually concerned about the affordability or availability of the drug after the successful trial. Also, patients who have been recruited as participants in a drug trial may also be allowed access to ancillary care for health conditions that though are unrelated to the trial but might have been discovered during the course of the trial.

It is necessary that the investigator ensure that all relevant information regarding compensations, payments or reimbursements are contained in the protocol.

6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?

The starting point of explaining this under the Nigerian pharma-legal sphere would be noting the provisions of the Good Clinical Practice Regulations on this subject which provides that “no informed consent, whether oral or written, may include any exculpatory language through which the participant or the representative is made to waive or appear to waive any of the participant’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability of negligence”

Participants are protected first by being told honestly and without bias, what the known and potential risks are for participating in the trial. This information is to be presented to participants in the language they understand and are to form part of the informed consent document.

The Regulations also makes it mandatory for provisions regarding insurance and indemnity to cover the liability of the investigator and sponsor which may arise in relation to the clinical trial. Thus, in a typical clinical trial, insurance is provided to cover participants in case of any trial related injury that may be sustained by any participant. This way, participants of various clinical trials are protected by virtue of the insurance and or indemnity provisions contained in the Clinical protocol. It is worthy of note that where such provisions are not contained in the trial protocol, the Committee or NAFDAC might not grant final approval to such protocol and therefore the trial might not proceed.

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Also from this Legal Handbook

8. Regulatory, Pricing and Reimbursement Overview: Nigeria

The key facts about regulation, pricing and reimbursement in Nigerian Pharma. Prepared in association with Olaniwun Ajayi LP, a leading law firm in Nigeria, this is an extract from The Pharma Legal Handbook: Nigeria, available to purchase here for USD 99.

1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?

The regulatory authorities with jurisdiction over drugs, biologicals and medical devices in Nigeria are: (i) The National Agency for Food and Drug Administration and Control (NAFDAC); (ii) The National Drug Law Enforcement Agency (NDLEA); and (iii) The Federal Ministry of Health.

2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?

The regulatory framework for the authorization of drugs, biologicals and medical devices is the National Agency for Food and Drug Administration and Control Act Cap N1 LFN 2004 (the NAFDAC Act). The NAFDAC Act empowers NAFDAC to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale and use of food, drugs, cosmetics, medical devices, bottled water and chemicals.

NAFDAC has also issued various guidelines which supplement the NAFDAC Act.

As regards pricing and reimbursement of drugs, biologicals and medical devices, there is currently no fixed mechanism in place for drug price control or reimbursement in Nigeria.

3. What are the steps to obtaining authorization to develop, test, and market a product?

The process to development, test and marketing of products is regulated by NAFDAC through the NAFDAC Act and Guidelines made pursuant to it.

The NAFDAC Guidelines for Clinical Trial Application in Nigeria (NAFDAC Clinical Trial Guidelines) provides to the effect that no person shall commence a clinical trial or cause a clinical trial to be commenced or conduct a clinical trial, unless a written authorization in relation to the clinical trial has been granted NAFDAC.

The relevant application form for obtaining the authorization is available on the NAFDAC website (http://www.nafdac.gov.ng/). The NAFDAC Clinical Trial Guidelines provides detailed information on documents and information required for the application.

The accompanying documents for the application include but are not limited to the following: Informed Consent Form; Evidence of Accreditation of Ethics Committee by the National Health Research Ethics Committee; Ethics Committee Approval from participating centers; Minutes of Meeting held to approve the protocol and Informed Consent Form by the Ethics Committee; and Evidence of insurance cover for the trial participants.

Marketing of a product in Nigeria entails the registration of the product with NAFDAC; the advertising and labelling of the product.

For the purpose of registration, it is important to note that where the manufacturer is a foreign entity, a Power of Attorney, authorizing a local agent in Nigeria, to submit the application on its behalf would be required. The Power of Attorney must be valid for at least five (5) years and notarized by the Notary Public in the country of manufacture.

As it relates to advertisement of the products in Nigeria, the manufacturer must ensure an advertisement approval is obtained from NAFDAC, as well as a vetting approval from APCON prior to airing of the advert. Failure to obtain the necessary approvals may result in liability for the manufacturer.

In relation to labelling of a product, NAFDAC is required to first approve the label or artwork of the product before an application for its registration is submitted. Labelling is regulated by the relevant NAFDAC guidelines on the registration of medicine or medical device in Nigeria and is easily accessible on the NAFDAC website.

4. What are the approximate fees for each authorization?

Fees/Tariffs for different applications differ. The fees are set out in the NAFDAC Guidelines for the product type/category sought to be registered.

5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?

Once the application for the registration of a product is successful, NAFDAC issues a Certificate of Registration to the successful applicant. The registration of a product shall, unless cancelled earlier, be valid for a period of five (5) years and may be renewed for the same period.

An application for renewal of product registration certificate shall be made on the applicant’s letterhead addressed to Director of Registration and Regulatory Affairs Directorate at NAFDAC. The application is to be accompanied by supporting documents and evidence of payment of prescribed fees.

6. How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?

The application for registration of a brand name and generic product can be done through a single application process. The NAFDAC Guidelines for Registration of drugs, medical devices or other regulated products (be it imported or locally manufactured) prescribe the application process and supporting documents for the application and the guidelines is available on the NAFDAC website.
There is a requirement that the written application for registration of a product contains both the generic name and the brand name of the product (where it is applicable).

Further, the application process is slightly different for foreign manufacturers. A foreign manufacturer would in addition to documents required from a local manufacturer be required to provide the following:

a Power of Attorney, authorizing a local agent in Nigeria, to submit the application on behalf of the foreign manufacturer. The Power of Attorney must be valid for at least five (5) years and notarized by the Notary Public in the country of manufacture;
evidence that the foreign manufacturer is licensed to manufacture the product for sale in the country of origin;
evidence from the competent Health Authority in the country of manufacture that the sale of the product does not constitute a contravention of the drug laws of the foreign country;
the current Good Manufacturing Practice (GMP) of the manufacturing facility which must be authenticated by the Nigerian Embassy in the country of origin. In countries where no Nigerian Embassy exists, any Commonwealth or ECOWAS country can authenticate the document; and
a Letter of Invitation for GMP Inspection of the factory where the products are being manufactured.

7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?

In Nigeria, the registration or the consideration for registration of combination drug products are prohibited by NAFDAC unless where there is proven scientific documented evidence that such product has clinical advantage over the single drug available for the same indication(s) (Clause 10.2 of the NAFDAC Guidelines for Registration of Imported Drug Products in Nigeria).

Where registration is permissible for the combination products, the general procedure for registration of drugs with NAFDAC (as highlighted above) will apply.

8. How is compliance with regulations monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?

Compliance with regulation is monitored by the Investigation and Enforcement Directorate (the Directorate) of NAFDAC. It is a department of NAFDAC charged with the responsibility of ensuring compliance with NAFDAC’s mandate on regulatory activities.

The Directorate receives and investigates complaints and carries out/supervises the destruction of defective, dangerous, fake, counterfeit, substandard, expired, adulterated and/or unwholesome NAFDAC regulated products.

9. What is the potential range of penalties for noncompliance?

Section 25 of the NAFDAC Act provides for penalties for non-compliance with provisions of the Act. It provides that where there is a contravention of any NAFDAC Regulation (whether for registration, advertising, etc.), the person who contravenes shall be guilty of an offence and liable on conviction to the penalties specified in the regulation. However, where no penalty is specified in the regulation, the person shall be liable to a fine of ₦50,000 or imprisonment for a term of one year or both.

Further, where the offence is committed by a body corporate and it is proved to have been committed with the consent or connivance of, or to be attributable to a neglect on the part of any director, manager, secretary or other similar officer of the body corporate or any person purporting to act in any of those capacities, such person as well as the body corporate shall be guilty of the offence and liable on conviction to a fine of ₦100,000.

10. Is there a national healthcare system? If so, how is it administered and funded?

In Nigeria, national healthcare system is regulated by the National Health Insurance Scheme (NHIS or the Scheme). The aim of the Scheme is to attract more resources to the health care sector and improve access and utilization of healthcare services.

Contributions to the Scheme are voluntary/optional, and all contributions are required to be paid into the account of the health-insured’s chosen Health Maintenance Organisation (HMO).

The mode of funding or contribution to the Scheme is dependent on the programme in which the enrollee has signed up to. The three programmes available under the Scheme are: (i) Formal Sector Health Insurance Programme; (ii) Informal Sector Health Insurance Programme; and (iii) Vulnerable Group Health Insurance Programme.

It is noteworthy that funds in the formal sector are generated by pooling the contributions of employees and employers. The formal sector consists of the federal, state and local government, the organized private sector (which is a company with 10 employees and above), armed forces, police and uniformed services.

11. How does the government (or public) healthcare system function with private sector healthcare?

Currently the government (public) healthcare system functions completely separate from the private sector healthcare.

12. Are prices of drugs and devices regulated and, if so, how?

In Nigeria, pricing of drugs is not regulated; the price of a drug or device is not required by NAFDAC for the grant of market authorization/registration. Also, there is currently no pricing regulation in the country which defines maximum or minimum profit margins for both wholesale and retail medicines.

13. How are the drugs and devices used by patients paid for? What roles do public and private payers play?

In Nigeria, the public health system in some states provide medicines at no cost to the patients for certain conditions including malaria, tuberculosis, HIV/AIDS and expanded program on immunization vaccines for children.

In the private healthcare sector, the patients either pay for the treatment themselves or where they have health insurance, the insurer covers the treatment depending on their policy coverage. Some patients may however have to pay for a part of the cost of their treatment despite having health insurance as a result of their insurance policy not covering all or certain aspects of their treatment.

14. Who dispenses drugs and devices to patients and how are those dispensers compensated?

Only duly licensed pharmacists in Nigeria have the authority to supply, sell and dispense drugs to the public (Section 14(3) of the Pharmacists Council of Nigeria Act 1992). The sale of drugs shall take place in premises licensed for the purpose, which shall be subject to regular inspection by the pharmaceutical inspectors of the Pharmacists Council of Nigeria.

Nevertheless, it is permissible for certain over-the-counter drugs to be sold in patent medicine stores (commonly known as chemists in Nigeria) operated by Patent and Proprietary Medicine Vendor’s Licensees, particularly in areas where there are no licensed pharmacists in practice.

The premises for the sale of such drugs shall be approved and licensed and shall be subject to periodic inspection.

Compensation of pharmacists is done in accordance with their respective contracts of employment and the conditions contained therein.

15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?

Pharmacists have specific professional and legal responsibilities which is required in terms of the Pharmacists Council of Nigeria Act 1992 and the Code of Ethics for Pharmacists in Nigeria. One of these is the requirement to be registered with the Pharmacists Council of Nigeria and to obtain a practicing licensing for the practice of pharmacy and dispensing of medications in Nigeria.

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