The Pharma Legal Handbook: Zimbabwe

Keen to learn more about regulatory reform in Zimbabwe? Read on! Prepared in association with Honey & Blanckenberg, a leading law firm in Zimbabwe, this is an extract from The Pharma Legal Handbook: Zimbabwe, available to purchase here for USD 99.

 

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

Currently, there is no proposal for reform in the form of proposed or draft legislation.

The last major proposal for reform was the Public Health Bill, 2017 (Gazetted on 1 December 2017) its purpose is “to replace, update and align to the Constitution the law relating to Public Health. The present Public Health Act was passed in 1924 and needs updating to meet the current health challenges and needs of the population.”

The Ministry of Health and Child Welfare in its “Zimbabwe’s E-Health Strategy 2012-2017” proposed the enactment of legislation to “support the implementation and sustenance of the E-Health framework” and that the development of such legislative instruments was necessary support the implementation of E-Health as well as policies that would ensure compliance to agreed protocols and standards. E-Health is to be used in respect of maintenance of electronic medical record systems, the use of telehealth services where specialist services are provided to remote communities, mobile health, population level databases and electronic surveillance systems for decision makers with the power to decide on appropriate intervention to make a determination regarding what a targeted population needs.

The Ministry of Health and Child Welfare in its “Zimbabwe National Strategic Plan for Mental Health Services 2014 to 2018” proposed reform in respect of the legislation pertaining to mental health services including the review of the Mental Health Act [Chapter 15:12] to align the care of psychiatric patients with the current trends in the world with focus on treatment and rehabilitation.

The Ministry of Health and Child Welfare in its “National Health Strategy for Zimbabwe 2016 to 2020” recognised the need for further reform in the healthcare system in line with Section 76 of the Constitution of Zimbabwe, 2013, which provides for the right of citizens and permanent residents to access to basic healthcare services. The strategy identifies various areas requiring regulation including effective regulation to ensure that those covered by such schemes get fair health benefits, and that multiple pools are properly managed. The Strategy further identifies the need for regulation of technology in respect of the production and distribution of medicines, commodities and healthcare equipment.

The Ministry of Health and Child Welfare in its “Nutrition Communication Strategy, 2016”- the Ministry proposes the adoption of a food fortification regulatory framework in respect of the improvement of adolescent and maternal nutrition.

 

2. When are they likely to come into force?

Public Health Act [Chapter 15:17] came into force on 31 August 2018 repealing the Public Health Act [Chapter 15:09].

Zimbabwe’s E-Health Strategy 2012-2017 – no draft legislation or draft proposals to implement E-Health.

Zimbabwe National Strategic Plan for Mental Health Services 2014 to 2018 – no draft legislation or draft proposals.

National Health Strategy for Zimbabwe 2016 to 2020 – no draft legislation or draft proposals.

The Ministry of Health and Child Welfare in its “Nutrition Communication Strategy, 2016” – no draft legislation or draft proposals.

 

Also from this Legal Handbook

A brief overview of the situation regarding patents & trademarks in Zimbabwe. Prepared in association with Honey & Blanckenberg, a leading law firm in Zimbabwe, this is an extract from The Pharma Legal Handbook: Zimbabwe, available to purchase here for USD 99.

 

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

Patent Protection

The Patents Act [Chapter 26:03], provides that in order to qualify for patent protection, an invention must consist of patentable subject matter and satisfy the basic requirements of patentability, being novelty, inventive step and industrial applicability.

In order to satisfy the requirement of novelty, an invention must not form part of the prior art. Prior art refers to all the relevant technical knowledge available to the public anywhere in the world prior to the first filing date of the relevant patent application. It is important to prevent disclosure of the invention prior to filing the patent application otherwise this destroys novelty. The Zimbabwe Patents Act requires absolute novelty; this means that the prior art against which an invention is tested consists of all information which has been made public in Zimbabwe and elsewhere in the world.

In order to satisfy the requirement for inventive step, also known as the non-obvious requirement, the invention must not be obvious to a person skilled in the particular field of technology taking into account the prior art.

In order to satisfy the requirement for industrial applicability, the invention must be capable of being used or applied in trade or industry. In addition, the invention must be useful and provide some practical benefit.

Trade Mark Protection

The Trade Marks Act [Chapter 26:04] provides that in order to qualify for trade mark protection, a mark should be capable of distinguishing the goods or services in relation to which the mark is used or proposed to be used, from the same kind of goods or services of any other person Distinctiveness is a requisite for registration in Part A of the Register. Capability to distinguish is a requirement for registration in Part B of the Register.

 

2. What agencies or bodies regulate patents and trademarks?

Patents and trade marks are regulated by the Zimbabwe Intellectual Property Office. It is an administrative body operating under the Ministry of Justice, Legal and Parliamentary Affairs.

In addition, the African Regional Intellectual Property Organisation (ARIPO) which is based in Harare, Zimbabwe grants and administers intellectual property rights on behalf of its Member States (Botswana, The Gambia, Ghana, Kenya, Lesotho, Liberia, Malawi, Mozambique, Namibia, Rwanda, Sao Tome and Principe, Sierra Leone, Somalia, Sudan, Swaziland, Uganda, United Republic of Tanzania, Zambia and Zimbabwe).

 

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

Patents

In terms of Section 2A of the Patent Act, a patent can be granted in respect of any invention that meets the requirements of patentability subject to the below exceptions wherein a patent cannot grant:

1. Diagnostic, therapeutic or surgical methods for the treatment of human beings or animals;
2. Plants and animals other than micro-organisms; and
3. Biological processes for the production of plants or animals, other than microbiological processes.
4. Mere discoveries
5. Scientific theories and mathematical methods.

Further, non-patentable subject matter includes inventions the commercial exploitation of which is necessary to protect public order or morality, to protect human, animal or plant life or health or to avoid serious prejudice to the environment.

Trade Marks

In terms of the Trade Marks Act, a trade mark can be protected in respect of the below:

1. The name of a company, individual or firm, represented in a special or particular manner;
2. The signature of the applicant for registration or some predecessor in his business;
3. An invented word or invented words;
4. A combination of words, letters and numerals
5. Drawings, symbols, three dimensional signs and colours
6. A word or words which have no direct reference to the character or quality of the goods or services in respect of which the trade mark application is being made, according to its ordinary meeting , geographical name or surname;
7. A trade mark which has become capable of distinguishing through use.

The below trade marks cannot be protected:

1. The use of which would be likely to deceive or cause confusion; or
2. The use of which would be contrary to law;
3. Which comprises or contains scandalous matter; or
4. Which is prescribed to be a prohibited mark; or
5. Which for any other reason, would not be entitled to protection in a court of law.

Further, there is no protection for a trade mark which is:

1. identical to a trade mark belonging to a different proprietor and already on the register in respect of the same goods or services or description of goods or services or description of goods and services; or
2. so nearly resembles a trade mark belonging to a different proprietor and already on the Register in respect of the same goods or services or description of goods or services as to be likely to deceive or cause confusion; or
3. a reproduction, imitation or translation of a familiar foreign mark which is well known in Zimbabwe.

 

4. How can patents and trademarks be revoked?

Patents

Patents can be revoked upon an application to the High Court of Zimbabwe or the Intellectual Property Tribunal by an interested person, including the state on any of the grounds in which the patent might have been opposed.

Grounds for opposing a patent are limited to the following:

1. that the applicant is not a person entitled under section six to make the application;
2. that the application is in fraud of the rights of the person giving such notice or of any persons under or through whom he claims;
3. that the invention does not relate to an art, whether producing a physical effect or not, process, machine, manufacture or composition of matter which is capable of being applied in trade or industry;
4. subject to section twenty-six, that the invention is obvious in that it involves no inventive step having regard to what was common knowledge in the art at the effective date of the application;
5. that the invention, in so far as is claimed in any claim of the complete specification, is not useful;
6. that the complete specification does not fully describe and ascertain the invention and the manner in which it is to be performed;
7. that the claims of the complete specification do not sufficiently and clearly define the subject-matter for which protection is claimed;
8. that the complete specification does not disclose the best method of performing the invention known to the applicant at the time when the specification was lodged at the Patent Office;
9. that the application form or any other document filed in pursuance of the application contains a material misrepresentation;
10. that the matter described or claimed in the complete specification is not the same as that described in the provisional specification, and – (i) in so far as it is not described in the provisional specification, was not new at the date when the complete specification was lodged at the Patent Office; or (ii) forms the subject of a pending application made in Zimbabwe for a patent the effective date of which is prior to the date on which the complete specification was lodged at the Patent Office;
11. in the case of a Convention application, that the specification describes or claims matter other than that for which protection has been applied for in the Convention country and that such other matter either – (i) forms the subject of an application for a patent in Zimbabwe which, if granted, would bear a date in the interval between the lodging of the application in the Convention country and the effective date of the application in Zimbabwe; or (ii) is not an invention as defined in this Act;
12. that the invention was not new at the effective date of the application;
13. that the specification includes claims which, in terms of subsection (1) of section thirteen, should have been refused.

According to Section 45 of the Patents Act, an application for the revocation of a patent must state the grounds on which the applicant relies and set out particulars of the facts in support of the grounds.

Trade Marks

In terms of Section 37 of the Trade Marks Act, a trade mark can be revoked by expungement from the Trade Marks Register. An application for expungement may be made to the Registrar of patents and trade marks or the Intellectual Property Tribunal by a person aggrieved by any of the following:

1. the non-insertion in or omission from the Register of any entry; or
2. any entry made in the Register without sufficient cause; or
3. any entry wrongly remaining on the Register; or
4. any error or defect in any entry in the Register.

 

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

Patents

Patent rights are territorial, resultantly; foreign patents which are not registered in Zimbabwe through the Zimbabwe Intellectual Property Office or the African Regional Intellectual Property Organisation designating Zimbabwe or offered protection. Only patents registered in Zimbabwe or ARIPO designating Zimbabwe are enforceable.

Certain pharmaceuticals are restricted from being imported into Zimbabwe (such as Antacids, Aspirin, Cotrimoxazole, Amoxicillin, Ibuprofen, Paracetamol) without specific import licensing (Statutory Instrument 18 of 2016), which licence will only be granted if it can be demonstrated that no Zimbabwean manufacturer is producing the same.

Trade Marks

In accordance with the principle of national treatment foreign trade marks registered in Zimbabwe are recognised and protected in the same manner as local trademarks.

Section 9E of the Trade Marks Act provides for protection of familiar foreign trade marks which are not registered in Zimbabwe. These trademarks are recognized and protected if they are well known marks in Zimbabwe. A foreign familiar mark is a mark which is well known in Zimbabwe as being the mark of a person who –

1. Is a national of a convention country to which Zimbabwe is a party; or
2. Is domiciled in, or has a real and effective industrial or commercial establishment, in a convention country to which Zimbabwe is a party, whether or not that person carries on business or has any goodwill in Zimbabwe.

Upon application by the proprietor of a familiar foreign mark, the High Court of Zimbabwe or the intellectual Property Tribunal may prohibit the use in Zimbabwe of a trade mark which constitutes, or the essential part of which constitutes a reproduction, imitation or translation of the familiar foreign mark.

The proprietor of a familiar foreign mark must within a month of instituting action in either the high Court or intellectual Property Tribunal, apply for registration of the said mark in Zimbabwe.

 

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

Other ways in which medicines or devices can be protected aside from patents and trade marks are through registration with the Medicines Control Authority of Zimbabwe.

 

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

Section 2A of the Patents Act prohibits the granting of patents in respect of:

1. diagnostic, therapeutic or surgical methods for the treatment of human beings or animals; or
2. plants and animals, other than micro-organisms; or
3. essentially biological processes for the production of plants or animals, other than microbiological processes.

Patents may also not be granted in respect of mere discoveries, scientific theories and mathematical methods.

 

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

Patent

A license agreement with a foreign licensor need not be approved by the Zimbabwe Intellectual Property Office. In the event, however, that a person is not able to obtain a licence under a patent on reasonable terms that person may, within a period of 6 months from the initial request for a voluntary licence, apply to the Registrar in the prescribed manner for a compulsory licence on the ground that the reasonable requirements of the public with respect to the invention in question have not been or will not be satisfied (Section 31 of the Patents Act)

Trade Marks

It is not mandatory to register a trade mark license agreement under Zimbabwean law, but such registration is provided for under Section 33 of the Trade Marks Act, and various rights will be availed to a “registered user” under that section, which makes registration desirable. Where a licence is recorded with the Zimbabwe Intellectual Property Office, use by the licensee is deemed use by the licensor. However, use by a licensee in the absence of recordal is not considered permitted use and can result in the expungement of a trade mark for non-use. Further, in order for the licensee to institute legal proceedings resulting from the infringement of the trade mark it is necessary for the licence to be recorded with ZIPO.

 

Also from this Legal Handbook

An intro to the legal situation for product liability in Zimbabwe. Prepared in association with Honey & Blanckenberg, a leading law firm in Zimbabwe, this is an extract from The Pharma Legal Handbook: Zimbabwe, available to purchase here for USD 99.

 

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

Zimbabwe has recently passed a Consumer Protection Act [Chapter 14:14] (“the CPA”), which was gazetted on 10 December 2019.

In addition, the common law concept of delict law is recognised in Zimbabwe. Under the law of delict, property liability claims may be brought by way of aquilian action. This action is brought where there is patrimonial loss (G Feltoe A guide to the Zimbabwean Law of Delict, Chapter 2).

Damages may include actual damages which can be proven (including hospital expenses, loss of earnings and so on) as well as general damages relating to loss of dignity, emotional harm and the like.

 

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

Under the delictual law, if a manufacturer produces and markets a product which is defective, and a person can demonstrate that such an action was wrongful in that it breached the duty of the manufacturer to the consumer, the manufacturer could be held liable (Max Loubser et al The Law of Delict in South Africa 2009).

Section 10 of the CPA provides that a supplier is prohibited from selling of marketing any goods of services unless they conform to the mandatory safety and quality standards prescribed in accordance with law.

Section 16 of the CPA provides that the producer, trademark holder, importer, distributor or retailer of any goods is liable for any harm, caused wholly or partly as a consequence of, amongst others, supplying any unsafe goods or products which have a failure, defect or hazard.

 

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

There is a need to prove causation – namely that the person involved caused the harm, either directly or indirectly.

In terms of Section 16 of the CPA, producers can be found liable for harm caused by their goods. The CPA defines ‘goods’ as anything marketed for human consumption. Because medicines and devices are produced for human consumption, the above liabilities apply to producers of medicines.

This is in line with the provisions of South African law, which is persuasive in Zimbabwe, and which imposes strict liability on the part producers, importers, distributors or retailers.

 

4. How can a liability claim be brought?

A liability claim would be brought by the injured person, or his family or dependents in the case of death. The claim would brought in either the Magistrates’ Court or the High Court, depending on the monetary value, by way of action proceedings.

In terms of the CPA, a liability claim can be brought either by the consumer or by accredited Consumer Protection Advocacy groups. If brought by a Consumer, Section 65 of the CPA provides that the consumer may bring the claim to the Consumer Protection Commission, the designated consumer protection organisation or directly to the court. The Court that a consumer may approach are either the Small Claims Court, the Magistrates Court or the High Court depending on the value of the claim.

 

5. What defences are available?

Under delictual law, it would be a defence to a claim to demonstrate that a person had consented to the harm by assumption of risk (for example, if the harm caused was disclosed as being possible in terms of a known side effect) or where they can demonstrate that there was a prior agreement not to claim, through accepting a limitation of liability. In addition, it may be a defence to claim, if it can be demonstrated that the fault was due to someone else’s actions, as would be the case if a pharmacist sold medication which was passed its sell-by date.

In terms of Section 17 of the CPA, defences available to anyone against whom a claim for product liability has been made are as follows:

1. the unsafe product characteristic, failure, defect or hazard that results in harm is wholly attributable to compliance with any public regulation;
2. the person proceeded against did not at any time supply the product to another;
3. the alleged unsafe product characteristic, failure, defect or hazard –

1. did not exist in the goods at the time it was supplied by that person to another person alleged to be liable; or
2. was wholly attributable to compliance by that person with instructions provided by the person who supplied the goods to that person, in which case subparagraph (i) does not apply;

d. it is unreasonable to expect the distributor or retailer to have discovered the unsafe product characteristic, failure, defect or hazard, having regard to that person’s role in marketing the goods to consumers.

In addition, prescription is also a valid defence, and the prescription period in Zimbabwe is three years.

 

Also from this Legal Handbook

The ins and outs of traditional medicines and OTC products in Zimbabwe. Prepared in association with Honey & Blanckenberg, a leading law firm in Zimbabwe, this is an extract from The Pharma Legal Handbook: Zimbabwe, available to purchase here for USD 99.

 

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

The regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices as per the Medicines and Allied Substances Control (Complementary Medicines) Regulations, 2015 (“the Complementary Medicines Regulations”) necessitate that an application must be made for approval of the medicine by either the principal or any other person acceptable to the Medicines Control Authority of Zimbabwe “the Authority”. In addition, every complementary medicine shall, unless otherwise directed by the Authority, bear a label on the package which is printed in clear letters in the English language and any other language as directed by the Authority.

After approving a complementary medicine, the Director General of the Authority issues a certificate to the agent or principal. Furthermore, complementary medicines may only be sold on premises licensed by the Authority or authorised in terms of a general dealer’s license.

 

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

According to Section 21(1) of the Complementary Medicines Regulations, traditional, herbal, complementary and alternative medicines can be advertised to the public, however such advertisements can only be published with the approval of the Authority in writing.

 

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

As per Section 21 (3) of the Complementary Medicines Regulations, the only health, advertising and marketing claims permissible are those that fall within the scope of evidence submitted upon the application for approval of such medicines to the Authority. The evidence, when approved by the authority, has to be incorporated into the approved package inset of the complementary medicine. In addition, every complementary medicine approved should bear the words “NO APPROVED THERAPEUTIC CLAIMS” on the label, unless exempted by the authority.

 

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

The Act defines “medicine” as:

“any substance or mixture of substances which is used, or is manufactured, sold or represented as suitable for use, in—

1. the diagnosis, treatment, mitigation or prevention of disease or any abnormal physical or mental state or the symptoms thereof in man or in animals; or
2. restoring, correcting or modifying any physical, mental or organic function in man or in animals.

As such, all the previously set out requirements relating to medicines would apply, even to over the counter medications.

Section 37 of the Regulations sets out that all medicines, including over the counter medicines ought to be labelled to show the below:

1. the name and address of the principal;
2. the name and address of the manufacturer;
3. the approved name of the medicine which shall be of greater size and prominence than the proprietary name (trademark), if any, of the medicine;
4. the housemark, if any, of the principal or manufacturer of the medicine;
5. the quantity and strength of the active ingredient of the medicine;
6. the name and percentage of any bacteriostatic or bactericidal agent which is added to the medicine as a preservative;
7. the date of manufacture and expiry date of the medicine;
8. the batch number of the medicine;
9. the quantity of the medicine in the package;
10. the strength of the medicine (where applicable);
11. the requirements for the method of storage or other necessary precautions for the preservation of the medicine;
12. the category of distribution of the medicine which may be represented by words or symbols as set out in the Sixth Schedule;
13. the dosage of the medicine and the directions for use;
14. any warning notices which shall be in a colour other than the colour of the particulars referred to in paragraph (a) to (m);
15. any other particulars as may be directed by the Authority.

In addition, over the counter medicine must be sold in unbroken packs.

 

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

Over the counter medicines may only be sold from locations or premises which are licensed by the Authority or authorized by a general dealer’s license issued in terms of the Shop Licenses Act.

 

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

As per the National Medicines Policy of Zimbabwe, published by the Directorate of Pharmacy Services in 2011 (“the National Policy”), health, advertising and marketing claims that may be made must be based on scientific evidence which is consistent with the World Health Organisation criteria for medicine promotion and the conditions under which such products have been registered for marketing by the authority.

 

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

In accordance with the National Policy, over the counter products can be marketed and advertised directly to the public provided that the product is registered with the Authority. Furthermore, advertisement and other forms of promotion directed to the general public shall be permitted only for medicines that have been licensed for sale as “over the counter” products without prescription; such advertisements and communications shall be of a technical nature and attuned to the public’s needs and level of understanding. Advertising and promotional materials and related activities will be monitored by the Authority to ensure their consistency with the conditions applicable to the products concerned and the approvals granted.

 

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

A prescription only product can be converted to an over the counter product upon application to the Authority for a change in the registration of that product.

 

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

In order to import traditional medicines or OTC products, a permit issued by the Authority is required. Furthermore, with regards to wholesale dealers, one has to be duly appointed as an authorized importer by the principal of the medicine or OTC.

Under the provisions of Section 5(2) of the Medicines and Allied Substances Control (Import & Export of Medicines) Regulations, 2008, an application for the issue of a permit should be made to the Director-General of the Authority and must include the following:

1. the name and address of the importer; and
2. the trade name or proprietary name of the medicine, if any; and
3. the International Non-Proprietary Name (INN) or generic name of the medicine; and
4. its strength; and
5. the total quantity of the medicine; and
6. name and address of the supplier; and
7. the name and address of the manufacturer, if not the same as the supplier; and
8. the Zimbabwean registration number; and
9. the cost, insurance, freight (CIF) value of the consignment; and
10. the port of entry.

In addition to such terms and conditions as may be fixed in a permit to import any traditional medicine or OTC, the importer shall comply with the following conditions-

1. no import of any medicine shall be done through ordinary or registered post; and
2. the importer of any medicine shall notify the Authority, within 30 days of the import or export of any medicine by him or her.

 

Also from this Legal Handbook

Marketing, manufacturing, packaging & labeling, advertising in Zimbabwe – an overview. Prepared in association with Honey & Blanckenberg, a leading law firm in Zimbabwe, this is an extract from The Pharma Legal Handbook: Zimbabwe, 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?

• The process is set out in the Medicines Control Authority of Zimbabwe (Guidelines on Submission of Documentation for Registration of Complementary Medicines) and Section 9 of the Medicines Control Authority of Zimbabwe Guidelines for Advertising and Promotion of Medicine in Zimbabwe.
• An application form together with a dossier of supporting documents has to be submitted to the registration department at the Medicines Control Authority of Zimbabwe (MCAZ). The Licensing and Advertising Committee of the Authority considers all advertising material submitted for approval. The Committee meets regularly on the first Tuesday of every month.
• Advertisements must be submitted at least two weeks prior to the meeting to ensure they are included on the agenda for the next meeting.
• To facilitate the review process applicants are encouraged to limit the indications claimed to the following:

1. Those derived from data already submitted to the Authority during registration of the product that have been substantiated and approved.
2. The Authority reserves the right to limit the claims made on advertisements directed to the public. Applicants should not use the advertisement before written approval is given.
3. For printed material ONE colour copy and NINETEEN other good copies should be submitted. The Authority may reject any unsatisfactory copies.

• The advertisements should always contain the following and any other requirements as may be deemed necessary by the Authority.

1. Standard warnings where applicable. These should be of a large enough size
2. To be easily readable on the advertisement or be read loud enough to be heard by listeners or displayed long enough to be seen by viewers respectively.
3. Approved Name(s) and strength of all the active ingredient(s) per unit dose should be stated.
4. Name and address of manufacturer or distributor.
5. The registration number and category for distribution should be indicated.

• If approved/disapproved, the Authority issues an approval/disapproval letter, which is then communicated, to the customer.
• In addition, in accordance with the provisions of Section 6 of Part II of the Fifth Schedule of the Broadcasting Services Act [Chapter 12:06]: “(2) A broadcaster must not broadcast an advertisement relating to a medicine unless the text of the proposed advertisement has been approved –

1. by the Secretary for Health and Child Welfare under subparagraph (3); or
2. by the Minister on appeal to the Minister under this paragraph.

• A person may apply, in writing, to the Secretary for Health and Child Welfare for approval of the text of a proposed advertisement relating to a medicine.
• If an application is made, the Secretary for Health and Child Welfare may, in writing, approve or disapprove the text”.

The above power may be delegated to the Medicines Control Authority of Zimbabwe, which has a Licensing and Advertising Committee.

 

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

• In accordance with the MCAZ Guidelines on Submission of Documentation for Registration of a Multisource (Generic) finished pharmaceutical product, the process is the same as above.
• However, Applications for generic solid dosage forms (tablets, capsules, suspension and the like) medicines may require the submission of a bio-equivalence study.

 

3. What are the typical fees for marketing approval?

The typical fees for the approval of advertisements or promotional material is $50.00 as provided for in the MCAZ Circular on Payment of Fees (REF B/279/35/12/12018).

NB. The fee is set out in United States dollars, but following the enactment of the Finance (No 2) Act of 2019, all Acts and Regulations which sounded in United States dollars, now sound in Zimbabwe dollars at a parity rate. In some instances, however, Regulatory bodies and Government departments have been authorised to charge foreign companies and individuals in foreign currency, so it is possible that the currency of payment may vary.

 

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

• In accordance with the provisions of Section 34 of the Regulations, once a medicine has been registered, the registration remains in effect until it is cancelled, subject, however, to the payment of an annual fee.
• In accordance with Section 11 of the Regulations, The period of authorization for a person or premises in respect of manufacturers, pharmacies, pharmacists, and pharmacy technicians is twelve months. An application for the renewal shall be lodged with the Director-General, in triplicate, in Form M.C. 3 for the renewal of a license for premises and in Form M.C. 4 for the renewal of a license for a person before the expiry of such license and shall be accompanied by the appropriate fee in respect of each license.
• Where an application for the renewal of a license has been lodged with the Director-General, the validity of the license shall, where the applicant has not been given notice of the renewal or refusal of the application by the date of expiry of such license, continue after the date of expiry until the decision of the Authority on the application is notified to the applicant by the Director-General.

 

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

The pharmacovigilance activities are coordinated by the MCAZ in collaboration with the Ministry of Health and Child Care (MoHCC) and all key stakeholders both in the public and private health sector including the pharmaceutical industry. Healthcare professionals are to consider pharmacovigilance practice as a professional responsibility (see http://www.mcaz.co.zw/index. php/how-we-regulate/ pharmacovigilance/pharmacovigilance-centre).

There is, however, no statutory post approval pharmacovigilance protocol required by MCAZ.

 

6. Are foreign marketing authorizations recognized?

As per the Medicines Control Authority of Zimbabwe (Guideline on submission of documentation for registration of complementary medicines), foreign marketing authorisations are recognised.
However, one has to list the countries in which

• The FPP (Finished Pharmaceutical Product) has been granted a marketing authorisation,
• The FPP has been withdrawn from the market,
• An application for the marketing of the FPP has been rejected, deferred or withdrawn.

 

7. Are parallel imports of medicines or devices allowed?

This is not legislated in Zimbabwe.

 

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?

This is not legislated in Zimbabwe.

 

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

The manufacturing of medicines and devices is regulated by Medicines Control Authority of Zimbabwe (MCAZ). It is regulated in terms of the Act and the Regulations.

 

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)?

As per the MCAZ Good Manufacturing Practice Guidelines published on 10 December 2019, all prospective and licensed pharmaceutical manufacturers, as well as international pharmaceutical manufacturers who have medicines registered in Zimbabwe, must comply with the World Health Organisation Good Manufacturing Practice.

 

11. What is the inspection regime for manufacturing facilities?

The MCAZ conducts inspections in line with current WHO GMP guidelines. Upon submission of an application of a medicine with the Authority, the manufacturer should request for inspection of their site through email: gmp@mcaz.co.zw and the request should be accompanied with an updated site master file and list of products submitted for registration. A pro forma invoice will henceforth be issued and dates for inspection will be scheduled upon receipt of payment for the inspection.

 

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

There is no provision for the same under Zimbabwean law.

 

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

This process is set out in Sections 3 – 6 of the MCAZ Guidelines for Good Wholesaling Practice of Pharmaceuticals.

BUILDINGS & GROUNDS

• Warehousing of pharmaceuticals should be carried out in buildings or parts of buildings that have been built for, or adapted to, this purpose.
• The grounds should be established and maintained so as to minimize ingress into the buildings of dust, soil or other contaminants and should be maintained in an orderly condition. They should be free of accumulated waste, dirt and debris. Waste should be collected in designated closed containers and disposed of at frequent intervals.
• Buildings should be kept free of rodents, vermin, birds, pets and pests.
• Buildings should provide protection for the pharmaceuticals from contamination and deterioration, including protection from excessive local heating or undue exposure to direct sunlight. The pharmaceuticals received or dispatched at receiving or dispatch bays, platforms or areas should also be protected from dust, dirt and rain.
• Buildings should have sufficient security to help prevent misappropriation of the pharmaceuticals.
• Sufficient space should be provided for the orderly receipt, warehousing and dispatch of pharmaceuticals and, in particular, a quarantine area for isolation when necessary, including isolation of faulty packs and recalled goods. Each area in the wholesale should be physically separated and demarcated.
• Buildings and fixtures should be kept clean and well maintained. Cleaning equipment should be stored in hygienic conditions.
• Sufficient lighting should be provided to enable all operations to be carried out accurately and safely.

FACILITIES

• Storage facilities should protect goods from deterioration. The conditions of storage for the goods should be compatible with the storage conditions specified on their labels. All pharmaceuticals should be stored off the floor.
• Controlled storage environments, e.g. deep freeze, refrigeration, should be monitored, using suitable temperature recording devices and the records reviewed and filed. Refrigerated and freezing storage environments should be fitted with signals to indicate that refrigeration has failed. The signal should permit resetting only by an authorized person.
• Temperatures in other areas where goods requiring specific storage conditions are held should be monitored and the results tabulated and analysed to demonstrate the suitability of these areas for their purposes.
• If any temperature is found to have deviated outside the relevant recommended conditions for an extended time, the manufacturer of the goods should be consulted and the suitability of the product for use resolved.
• Instruments or equipment used for monitoring temperature should be calibrated on a regular basis to ensure their accuracy. Records for the calibration should also be kept on the premises.
• Special storage facilities should be provided for drugs of addiction, “Dangerous Drugs” as required by the legislation.
• Incompatible activities such as manufacture (including repackaging) or the handling of toxic chemicals should be avoided in areas in which pharmaceuticals are handled by wholesale.

PERSONNEL

• Pharmacists or Pharmacy Technicians bearing the responsibility for ensuring that products/materials are correctly handled, stored and distributed, should have the education, training experience or combination of these elements that will allow them to effectively discharge this responsibility.
• Operating personnel should be trained to perform assigned duties and functions at an acceptable level. Records of any training relevant to their functions should be kept.
• Procedures and job descriptions for employees and other persons having access to the products must be designed and administered to minimize the possibility of drugs coming into unauthorized possession.
• During operating hours, the business must at all times be conducted under the continuous personal supervision of a licensed pharmacist or licensed pharmacy technician.
• Premises dealing in dangerous drugs should be under the supervision of a licensed pharmacist.

STOCK HANDLING AND STOCK CONTROL

• Handling and storage of pharmaceuticals should be in accordance with established procedures designed to prevent contamination or deterioration, damage to packs or confusion of products. Particular care should be given to maintaining the integrity of seals on packs of sterile pharmaceuticals. Attention should be paid to any special instructions from the manufacturer relating to handling or storage of the pharmaceuticals.
• Importers should take all reasonable measures to ensure that pharmaceuticals are not mishandled or exposed to adverse storage conditions at ports of entry e.g. airports.
• Storage areas should be adequate and organized to permit segregation and identification of the various materials and products stored and should enable stored goods to be easily maintained in a clean, dry and orderly condition. Particular care should be taken to avoid mould growth in refrigerated rooms or cabinets.
• There should be a system to ensure stock rotation, with frequent regular checks that the system is operating correctly. The system should ensure that pharmaceutical products due to expire first are sold and/or distributed first (FEFO). Where no expiry dates exist for the products, the FIFO principle should be applied. Products beyond their expiry date or shelf life should be removed from usable stock and neither sold nor supplied.
• Spilled substances should be cleaned up promptly and rendered safe as quickly as practicable and under the supervision of a responsible person. A written procedure for dealing with spillage of items of special hazard, such as cytotoxic drugs, should be available.
• Measures should be taken to demonstrate that restricted goods are not misappropriated.
• Goods bearing an expiry date must not be received or supplied after their expiry date or so close to their expiry date that this date is likely to occur before the goods are used by the consumer. Such goods must be withdrawn from sale and quarantined pending disposal in accordance with agreements between the wholesaler and the supplier.
• Precautions must be taken to prevent unauthorized persons from entering storage areas. Areas with medicines should be kept locked in the absence of the supervisor to restrict access by unauthorized persons.

 

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

As set out in Section 37(1) of the Regulations:

• The name of the active ingredient(s) using either international non-proprietary names (INN) or the approved generic name of the drug;
• The brand name;
• Content of active ingredient(s) per dosage form or regimen;
• Name of other ingredients known to cause problems;
• Approved therapeutic uses;
• Dosage form or regimen;
• Side-effects and major adverse drug reactions;
• Precautions, contraindications and warnings;
• Name and address of manufacturer or distributor;
• Reference to scientific literature as appropriate.

 

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

• Generally, no person shall sell any registered medicine unless it is labelled with its registered name and registered number, in addition to any other prescribed requirements. Where a medicine is required by this Act to be labelled with any information, such information shall be written, printed or otherwise marked on a label which is attached or affixed to the package of that medicine ; or packed with and refers to that medicine. The Authority may, if it deems it expedient, direct that the name and address of the manufacturer of a particular medicine shall not appear on the packages. Every medicine shall, where possible, be marked with the house mark of the principal or manufacturer of the medicine, as the case may be, and such other distinguishing mark for the purpose of identifying such medicine according to Section 37 (3) of the Regulations.

In terms of Section 60 of the Regulations, every person who dispenses a prescription preparation shall label such prescription preparation with—

• The registered name, strength and form of the medicine;
• Provided that this shall not apply where the prescriber has indicated that the prescription preparation shall not be so labelled: and
• The total quantity of the medicine; and
• The directions for use; and
• Any warnings; and
• The name of the patient; and
• The name of the prescriber;
• The name of the manufacturer; and
• The prescription reference number allocated to the prescription by the person dispensing the medicine; and
• The date on which the prescription preparation is supplied; and
• The name and address of the supplier.

 

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

• Generally, claims concerning medicinal drugs should be reliable, accurate, truthful informative, balanced, up-to-date, capable of substantiation and in good taste. They should not contain misleading or unverifiable statements or omissions likely to induce medically unjustifiable drug use or to give rise to undue risks. The word “safe” should only be used if properly qualified. Comparison of products should be factual, fair and capable of substantiation.
• This is in accordance with Section 6 of the MCAZ Guidelines for Advertising and Promotion of Medicines in Zimbabwe.

 

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

The Restriction on the advertisement of medicines is provided for in terms of Section 65 the Regulations. Those restrictions are amplified by the Guidelines for advertising and promotion of medicines in Zimbabwe (the Advertising Guidelines). The provisions provide as follows:

1. Advertising of medicines is only permitted where the Medicines Control Authority of Zimbabwe (the Authority) has given authority;
2. The offering of bonuses or discounts for the purchase of medicines in advertisements is prohibited;
3. Advertising is not permitted if it is calculated to lead to the use of medicines for the following conditions:

Alcoholism, Appendicitis, Arteriosclerosis, Cardiovascular disease, Cataract, Diabetes, Hernia, Kidney stone, Pneumonia, Prostate gland disorders, Epilepsy, Gallstones, Gangrene, Glaucoma, Hypertension, Hypotension, Infantile diarrhoea, Plague, Pleurisy, Locomotors or any other ataxia, All types of meningitis, Nephritis, Osteoarthritis, Sexually transmitted infections, Pneumoconiosis, Multiple sclerosis, Rheumatic fever, Rheumatoid arthritis, Malignant disease, Thrombosis, Tuberculosis, Poliomyelitis, Parkinson’s disease.

The exception to this prohibition is where the advertisement of the above medicines are directed at medical or veterinary professionals. This still requires the approval of the Authority.

• Advertising of psychotropic substances or any medicine which contains codeine or any of any of its salts is not permitted. This includes the window display for cough and cold preparations.
• Registered medicines may only be available to the public on the direction of a medical practitioner; dental practitioner or veterinary surgeon. Such medicines can only be advertised in a medical, dental, veterinary of pharmaceutical journal approved by the Authority.

 

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

In terms of Section 50 of the Regulations, no person shall sell any medicine unless the sale is effected on premises –

1. licensed in terms of Part V1of the Act; or
2. authorized in terms of these regulations;
3. authorized by a general dealer’s license issued in terms of the Shop Licenses Act [Chapter 14:17].

The requirements for the licensing of premises are provided for in terms of the Third Schedule of the Regulations. The schedule provides that the premises or planned premises must demonstrate the following standards:

1. satisfactory cleanliness. lighting, ventilation, tidiness, security, toilet facilities, washable impervious floor, washable painted walls and shelves;
2. wash hand basin and sink with hot and cold water;
3. storage of medicines; adequate protection from light, heat, moisture; prescription preparations to be out of reach of public; special storage place for dangerous medicines, namely fixed and lockable cupboards;
4. equipment; sufficient and adequate measures, balance and weights*; adequate refrigeration, mortar and pestle*, counting tray spatulas, sterilizing facilities;
5. prescription recording system: satisfactory prescription record (e.g. microfilm, computer, photocopy or patient profile cards or other approved recording system);
6. reference books: satisfactory reference books (e.g. latest Martindale, or British National Formulary, or next to latest British Pharmacopoeia or latest Pharmaceutical Codex or other approved references);
7. legislation: The Act as amended and up to date regulations made there-under; Dangerous Drugs Act [Chapter 15:02] as amended and up to date regulations made thereunder;
8. containers: cardboard cartons, vial, bottles (plastic/glass) and no other containers whatsoever unless approved by the Authority in writing; stock bottles for tablets, capsules and liquids;
9. any other requirements as may be required by the Authority.

 

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

In terms of Section 2 of the Act, ‘advertisement’ is defined as:
“in relation to any medicine, means any written, pictorial, visual or other descriptive matter or verbal statement or reference—

1. appearing in any newspaper or other publication; or
2. appearing on any television or cinematograph film; or
3. distributed to members of the public; or
4. brought to the notice of members of the public in any manner whatsoever; which is intended to promote the sale of that medicine.

There are no separate requirements for electronic marketing and advertising via email or via social media of medicines.

 

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

Medicines can be sold and advertised directly to consumers but with certain limitations. In terms of Section 40(1) of the Act, any false or misleading advertisement concerning a medicine is not permitted.

In terms of Section 40(2) of the Act where a condition is placed on the sale of any medicine, such as that such medicine can only be sold with a prescription by a doctor or dental surgeon, no one may advertise medicine in a manner that suggests that such condition does not apply.

In addition to the above, the Advertising Guidelines provide that:

1. Advertisements to the general public should help people to make rational decisions on the use of medicines determined to be legally available without a prescription;
2. Language which brings about fear or distress should not be used.
3. Advertisements should be reliable, accurate, truthful, informative, balanced, up-to-date, and capable of substantiation and in good taste.
4. While they should take account of people’s legitimate desire for information regarding their health, they should not take undue advantage of people’s concern for their health.
5. Bonus offers and discounts offered directly to the public are not permissible. However:

1. Point of sale indication of a price reduction may be permitted for medicines in the HR, HR (Vet), VMGD and P categories.
2. Indication of the selling price of medicines in the HR, HR (Vet) and VMGD categories may be permitted. Indication of a price reduction is however not permitted.

• Medicines can be sold directly to consumers. However, in terms of Section 17(1) of the Regulations, medicine can only be sold from registered premises, such premises being under the supervision of a registered pharmacist.
• In terms of Section 78(2) (a) of the Regulations a pharmacist may sell any medicine that does not require a medical practitioner’s prescription at the request of any person, subject to the condition that the pharmacist, by or under whose supervision the medicine is sold, before he delivers such medicine, makes an entry in his records stating –

1. the name and address of the person requesting the medicine and the person for whom it is intended; and
2. if the person is under the age of 12 years, the person’s age; and
3. the date on which the medicine is sold; and
4. the registered name, quantity, form and strength of the medicine; and
5. the total daily dose of the medicine; and
6. the directions for use

 

21. How is compliance monitored?

For the purposes of ensuring compliance with the various provisions relating to medicines, the Authority may appoint inspectors and analysers. In terms of Section 65 of the Act inspectors are appointed for the proper enforcement of the Act and (analysts as it may for the purposes of the testing, examination or analysis of medicines in terms of the Act.

In terms of Section 66 of the Act, the inspectors have the following powers:

1. To enter upon and search any premises, place, vehicle, vessel or aircraft at or in which there is or is on reasonable grounds suspected to be any medicine or any substance, device or articles;
2. To inspect any medicine or any substance, device or article to which any relevant regulations apply or any book, record or document found in or upon such premises, place, vehicle, vessel or aircraft;
3. To seize any such medicine, substance, device or article or any books, records or documents found in or upon such premises, place, vehicle, vessel or aircraft and appearing to afford evidence of a contravention of any provision of this Act;
4. To take so many samples of any such medicine, substance, device or article as he may consider necessary for the purpose of testing, examination or analysis in terms of the Act;
5. To enter any premises in respect of which an application for a license has been made in terms of the Act or which has been licensed in terms of the Act or which the inspector has reasonable grounds for believing are being used for the manufacture of a medicine or the carrying on of the business of a pharmacist in contravention of the Act.

 

22. What are the potential penalties for noncompliance?

Where the Authority is of the opinion that violations of the Act or its regulations have occurred it will invite comments from the person affected. Where no comments are submitted from the person required to submit his or her comments or after consideration of any comments submitted by the person concerned, the Authority is of the opinion for any reason specified that the license concerned should be cancelled or suspended or the purposes for which the license was issued should be altered or the conditions subject to which the license was issued should be varied, the Authority may direct the Director- General to:

1. to cancel the license and impose a period of disqualification not exceeding three years during which the person concerned shall not be issued with a license; or
2. to suspend the license; or
3. to alter the purposes for which the license was issued; or
4. to vary the conditions subject to which the license was issued.

There are also criminal penalties which may be imposed under Section 67 of the Act, and include penalties for:

• hindering or obstructing an inspector
• influencing a person under the age of 18 to use medicine in contravention of the Act,
• selling to or procuring medicine for a person under the age of 18,
• making misleading or false statements in an application for registration of any medicine, in connection with any medicine, in the course of selling any medicine of for purposes of the Act,
• selling medicines in containers on which there is a false or misleading statement regarding the contents,
• for the purpose of business, publishing any reports or certificates issued by an inspector, or
• selling or using for gain any veterinary medicine for the treatment of a person.

 

Also from this Legal Handbook

All legal aspects surrounding preclinical and clinical trial requirements in Zimbabwe. Prepared in association with Honey & Blanckenberg, a leading law firm in Zimbabwe, this is an extract from The Pharma Legal Handbook: Zimbabwe, 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?

There is no such requirement. The Medicines and Allied Substances Control Act only requires that a medicine be registered. In considering an application for registration, the Authority may, however, conduct any investigation or inquiry as it deems necessary into the medication (Section 33 of the Act), which could possibly include a clinical trial.

In addition, in terms of Section 23 of the Act, to ensure adequate protection of the general public against any risks or adverse effects from the clinical trial of any medicine authorized in terms of section eighteen, the Authority shall monitor such clinical trial from the beginning to the end so as to satisfy itself that all specific and general conditions subject to which the trial was authorized are being strictly observed by the person conducting the trial, and that to all intents and purposes the trial will achieve its aims and objectives.

 

2. How are clinical trials funded?

Clinical trials would be funded by the person or entity conducting the same.

 

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

Protocols must be approved by the Medicines Control Authority before they can be conducted.
In accordance with the MCAZ Guidelines for Good Clinical Trial Practice in Zimbabwe, protocols must contain the following:

1. Protocol title, protocol identifying number, and date. Any amendment(s) should also bear the amendment number(s) and date(s);
2. Name and address of the sponsor and monitor (if other than the sponsor);
3. Name and title of the person(s) authorised to sign the protocol and the protocol amendment(s) for the sponsor.
4. Name, title, address, and telephone number(s) of the sponsor’s medical expert (or dentist when appropriate) for the trial.
5. Name and title of the investigator(s) who is (are) responsible for conducting the trial, and the address and telephone number(s) of the trial site(s).
6. Name, title, address, and telephone number(s) of the qualified physician (or dentist, if applicable), who is responsible for all trial-site related medical (or dental) decisions (if other than investigator).
7. Name(s) and address(es) of the clinical laboratory(ies) and other medical and/or technical department(s) and/or institutions involved in the trial.

The protocols must also have the following background information:

1. Name and description of the investigational product(s);
2. A summary of findings from non-clinical studies that potentially have clinical significance and from clinical trials that are relevant to the trial;
3. Summary of the known and potential risks and benefits, if any, to human subjects.
4. Description and justification for the route of administration, dosage, dosage regimen, and treatment period(s);
5. A statement that the trial will be conducted in compliance with the protocol, GMP, GCP and the applicable regulatory requirement(s);
6. Description of the population to be studied; and
7. References to literature and data that are relevant to the trial, and that provide background for the trial.

It is also a requirement that the protocol must contain trial objectives and purpose which include a detailed description of the objectives and the purpose of the trial.

The protocol must also contain a Trial Design. This is the scientific integrity of the trial and the credibility of the data from the trial depend substantially on the trial. It should include:

1. A specific statement of the primary endpoints and the secondary endpoints, if any, to be measured during the trial;
2. A description of the type/design of trial to be conducted (e.g. double-blind, placebo controlled, parallel design) and a schematic diagram of trial design, procedures and stages.
3. Use of placebo alone as a trial treatment for trial subject is not acceptable where there is known treatment.
4. A description of the measures taken to minimise/avoid bias, including randomisation and blinding;
5. A description of the trial treatment(s) and the dosage regimen of the investigational product(s). Also include a description of the dosage form, packaging, and labelling of the investigational product(s);
6. The expected duration of subject participation, and a description of the sequence and duration of all trial periods, including follow-up, if any.
7. A description of the “stopping rules” or “discontinuation criteria” for individual subjects, parts of trial and entire trial.
8. Accountability procedures for the investigational product(s), including the placebo(s) and comparator(s), if any; and
9. Maintenance of trial treatment randomised codes and procedures for breaking codes.
10. The identification of any data to be recorded directly on the CRFs (i.e. no prior written or electronic record of data), and to be considered to be source data.

The requirements must also contain Selection and Withdrawal of Subjects. This must include:

1. Subject inclusion criteria;
2. Subject exclusion criteria;
3. Subject withdrawal criteria (i.e. terminating investigational product treatment/trial treatment) and procedures specifying:

1. When and how to withdraw subjects from the trial/investigational product treatment;
2. The type and timing of the data to be collected for withdrawn subjects;
3. Whether and how subjects are to be replaced.
4. The follow-up for subjects withdrawn from the investigational product treatment/trial treatment.
   It is also a requirement that information on the treatment of subjects be provided. This includes:

1. The treatment(s) to be administered, including the name(s) of all the product(s), the dose(s), the dosing schedule(s), the route/mode(s) of administration, and the treatment period(s), including the follow-up period(s) for subjects for each investigational product treatment/trial treatment group/arm of the trial;
2. Medication(s)/treatment(s) permitted (including rescue medication) and not permitted before and/or during the trial;
3. Procedures for monitoring subject compliance.

The protocol must also contain an assessment of efficacy which includes methods and timing for assessing, recording, and analysing of efficacy parameters.

An assessment of security must also be conducted. This includes:

1. Specifications of the efficacy parameter;
2. Methods and timing for assessing, recording, and analysing of efficacy parameters;
3. Procedures for eliciting reports of and for recording and reporting adverse event and intercurrent illnesses; and
4. The type and duration of the follow-up of subjects after adverse events.

Statistics to be provided include:

1. Description of the statistical methods to be employed, including timing of any planned interim analysis;
2. The number of subjects planned to be enrolled. In multi-centre trials, the numbers of enrolled subjects projected for each trial site should be specified. Reason for choice of sample size, including reflections on (or calculations of) the power of the trial and clinical justification;
3. The level of significance to be used;
4. Criteria for the termination of the trial;
5. Procedures for accounting for missing, unused and spurious data;
6. Procedures for reporting any deviation(s) from the original statistical plan (any deviation(s) from the original statistical plan should be described and justified in protocol and/or in the final report, as appropriate; and
7. The selection of subjects to be included in the analyses (e.g. all randomised subjects, all dosed subjects, all eligible subjects, valuable subjects).

Finally, all protocols must contain:

1. Direct Access to Source Data/Documents;
2. Quality Control and Quality Assurance of Data and Procedures;
3. Description of ethical considerations relating to the trial;
4. Data Handling and Record Keeping; and
5. Insurance of Trial Subjects.

 

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

In terms of Section 20(1) of the Act, where authorisation for a clinical trial for a medicine has been granted by the Authority, the following shall be furnished before the trial takes place:

1. in the case of a medicine for the treatment of adult persons, the voluntary written consents of all such persons taking part in the clinical trial have been freely obtained; and
2. in the case of a medicine for the treatment of minors or persons under legal disability, the voluntary written consents of their parents or legal guardians, as the case may be, have been freely obtained; and
3. in the case of a medicine for the treatment of animals, the voluntary written consents of the owners of all animals taking part in the clinical trial have been freely obtained.

 

5. May participants in clinical trials be compensated?

There is no prohibition against compensation for participation.

 

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

In terms of Section 23 of the Act, to ensure adequate protection of the general public against any risks or adverse effects from the clinical trial of any medicine authorized in terms of the Act, the Authority shall monitor such clinical trial from the beginning to the end so as to satisfy itself that all specific and general conditions subject to which the trial was authorized are being strictly observed by the person conducting the trial, and that to all intents and purposes the trial will achieve its aims and objectives.

Furthermore, if the Authority is satisfied that having due regard to the initial risks, discomforts or other adverse effects caused to persons or animals taking part in the trial it is in the public interest to stop or suspend the trial, it shall seek and obtain forthwith the Secretary’s written approval to stop or suspend the trial immediately, and, if such approval is obtained, the Authority shall notify in writing the person conducting the trial accordingly.

In terms of the Guidelines for Good Clinical Trial Practice in Zimbabwe, an ethics committee should be appointed before any clinical trial takes place. One of the Committee’s duties is to provide for compensation/treatment in the case of injury or death of a subject if attributable to a clinical trial, and any insurance or indemnity to cover the liability of the investigator and sponsor.

 

Also from this Legal Handbook

The key facts about regulatory, pricing and reimbursement overview in Zimbabwe. Prepared in association with Honey & Blanckenberg, a leading law firm in Zimbabwe, this is an extract from The Pharma Legal Handbook: Zimbabwe, 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 Medicines Control Authority of Zimbabwe (MCAZ) is the authority tasked with regulation of drugs and medical devices in Zimbabwe. It is established in accordance with the provisions of the Medicines and Allied Substances Control Act [Chapter 15:03] (hereinafter “the Act”).

It must be noted that only two medical devices (namely condoms and gloves) are currently regulated (under Statutory Instruments 183 of 2005 and 1 of 2016 respectively).

 

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

This is also governed in terms of the Medicines and Allied Substances Control Act. MCAZ authorises the manufacture, sale, registration and cancellation of registration of drugs. Dangerous drugs are governed in accordance with the provisions of the Dangerous Drugs Act [Chapter 15:02]. Authorisation to manufacture and sell drugs in terms of this Act is granted by the Minister on such terms and subject to such conditions, including, in the case of a license, the payment of a fee, as the Minister may fix.

There are however no regulations for the pricing and reimbursement of drugs, biological and medical devices in Zimbabwe. Drugs for the treatment of HIV and AIDs, malaria and tuberculosis are subsidised through grants and the payment of an AIDS levy by companies and individuals (Section 14(7) of the Finance Act [Chapter 23:04]) and are therefore more reasonably priced in Zimbabwe (see Schedule 2 – Limitations and Exclusions – National Social Security Authority Voluntary Informal Sectors Schemes Notice, 2018).

The lack of available foreign currency in Zimbabwe, together with high overhead costs, has, however, caused a sharp increase in the pricing of all drugs – both in the private and public sector (see Report to Parliament of Zimbabwe, dated 5 September 2019 – https://www.parlzim.gov.zw/national-assembly-hansard/download/2748_e5266 cde422c832cb75729a001cc16b9).

 

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

3.1 Developing a Drug

To develop a product, the manufacturer must make an application, which is accompanied by a dossier of the product to the Medicines Control Authority of Zimbabwe (Section 68 of the Medicines and Allied Substances Control (General) Regulations, 1991, hereinafter “the Regulations” as read with Sections 30 and 38 of the Act). The dossier must include all information relating to the product. The Registration department will thereafter review the dossier to ensure that the manufacturing of the product complies with the World Health Organisation Good Manufacturing Practices (GMPs) as set out in the MCAZ Good Manufacturing Practice Guidelines. If the product is registrable in Zimbabwe, the MCAZ inspectors will thereafter inspect the manufacturing plant at the manufacturers cost.

3.2 Testing a Drug

MCAZ has an established laboratory for purposes of quality control testing. The laboratory is a functional part of the MCAZ and they do not contract the service elsewhere (Section 25A of the Act).

In accordance with Sections 16 to 21 of the Act as read with Section 100 of the Regulations, to test a product through clinical trials, a signed application in the prescribed form, seeking authorisation of the Authority must be submitted to the Director-General. Where the medicine is to be tested on human beings, their names and physical identification particulars must be included in the application. Where the trials are conducted on animals, the kind of animals will take part in the clinical trial, and the names and addresses of the owners must also be included in the application. If the trial is to be conducted in a hospital or other medical institution, the medical superintendent or a senior medical officer of comparable rank of such hospital or medical institution must countersign the application. The Director General will thereafter submit the application to MCAZ, which will consider the application and consult with the Secretary. Where the application is granted, the trial shall only commence where:

1. voluntary written consents of all adult persons, taking part in the clinical trial have been freely obtained; and
2. in the case of a medicine for the treatment, the voluntary written consents of parents or legal guardians, as the case may be, of minors or persons under legal disability have been freely obtained; and
3. the voluntary written consents of the owners of all animals taking part in the clinical trial have been freely obtained; by the person conducting the trial.

3.3 Marketing a Drug

Prior to marketing both human and animal medicines in Zimbabwe, registration and approval by MCAZ is compulsory (Sections 29 and 30 of the Act). The application for registration must be done by or on behalf of the principal medicine owner. The applications for registration of conventional medicines are made through completing a statutory application form and providing MCAZ with a dossier of supporting documents (Section 31 of the Act). A prescribed form must be completed and submitted to the Evaluations & Registration Division by the applicant. The division staff will complete the form and send it back to the client with appropriate fees for the service required. There are the three main types of medicine applications that require different application fees namely generic medicines, new chemical entities and line extensions. Applications may only be submitted after payment for the application has been made.

In relation to finished pharmaceutical products, the following is also required:

(i) a list the countries in which:

• the finished product has been granted a marketing authorisation;
• finished product has been withdrawn from the market; and
• an application for the marketing of the finished product has been rejected, deferred or withdrawn.

(ii) The details of registration in the country of origin are required. Reasons for non-registration should be stated if the medicine is not registered in the country of origin.

(iii) Registration status in the country of manufacture should be indicated including any withdrawal, cancellations, suspension / revocations. The reasons for these should also be indicated.

A finished product, in relation to a medicine, means a medicine, which is wholly manufactured outside Zimbabwe, is imported into Zimbabwe, and is ready for sale without have to be relabelled or repackaged.
Applications are thereafter screened and may only be evaluated after passing screening. Re submission is permissible after failed screening. An extra fee is payable.

 

4. What are the approximate fees for each authorization?

The fees are set out in the First Schedule of the Regulations and are as follows:

Application for a Registration of a Medicine

(a) in the case of a medicine imported into Zimbabwe as a finished product for:

1. a new chemical entity including dosage form or a delivery system (human) $3000.00
2. a new chemical entity including dosage form or a delivery system (veterinary) $2000.00
3. a generic medicine (human) $2500.00
4. a generic medicine (veterinary) $1500.00
5. a line extension of a medicine (human) $1500.00
6. a line extension of a medicine (veterinary) $1000.00
7. orphan medicine $750.00
8. a previously registered medicine $750.00
9. resubmission of an application $600.00

(b) in the case of a medicine imported into Zimbabwe and which is re-labelled or repacked before being sold as –

1. human medicine $1500.00
2. veterinary medicine $900.00
3. a previously registered medicine $750.00
4. resubmission of an application $600.00

(c) in any other case –

1. human medicine $900.00
2. veterinary medicine $600.00
3. a previously registered medicine $750.00
4. resubmission of an application $600.00

(d) In the case of expedited review of –

1. a new chemical entity $4 500.00
2. a generic medicine $4000.00
3. a line of extension of a medicine $3000.00

Application to Conduct a Clinical Trial of a Medicine

If funded by a local sponsor –

1. human medicine $2000.00
2. veterinary medicine $1000.00
3. sub-study $1000.00
4. operational research study $1000.00
5. observational study $200.00
6. any other case $100.00

If funded by a non-resident –

1. human medicine phase 1 study $5000.00
2. human medicine phase II study $4000.00
3. human medicine phase III study or phase IV study $3000.00
4. veterinary medicine $1000.00
5. in any other case $500.00
6. operational $1000.00
7. bioequivalence/bioavailability $500.00
8. observational $200.00
9. in any other case $200.00

Marketing

1. Generic Medicines (excluding 15% VAT) per product application 2500.00 [foreign] $900.00 [local]
2. New Chemical Entities (excluding VAT) per product application $3000.00
3. (Biological and biosimilar medicines are included under this group) Line extensions excluding VAT per product application $1500.00

Approval of Advertisements or Promotional Material

1. in the case of an imported medicine $50.00
2. in the case of a medicine imported which is re-labelled and repacked before being sold $50.00
3. in any other case $50.00

 

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

Once a product is registered, it is published in a drug register. All licenses shall be valid for a period of 12 months (Section 11 of the Regulations). Thereafter, a yearly retention fee must be paid. The retention fee is paid for the permission to market a registered or approved product for one year and the fee is payable by 1 April each year (Section 35 of the Regulations). If this fee is not paid, registration will not be renewed (Section 34 of the Act).

 

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 Act and regulations do not distinguish between local manufacturers and foreign-owned manufacturers. Both local and international manufacturers are required to comply with Good Manufacturing Practices, which are published by the government.

 

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

There is no specific regulation relating to combination products. Each item will have to comply with the regulations specific to the product.

 

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 is monitored and evaluated by MCAZ inspectors (Section 65 and 66 of the Act). The inspectors are permitted to inspect premises where pharmaceutical activities are performed. These inspections are also a pre-requisite for the licensing of private facilities. Where inspections are legal requirements, these are the same for public and private facilities. The following inspections are carried out on local entities that are inspected for Good Manufacturing Practices compliance:

• Local manufacturers – Every two years
• Private wholesalers – Once a year
• Retail distributors – Once a year
• Public pharmacies and stores – Once a year
• Pharmacies and dispensing points if health facilities – Once a year (MCAZ Good Manufacturing Practice Guidelines)

The U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements are more strict that those relating to Zimbabwe. The inspectorate recognises manufacturers under the jurisdiction of “well-resourced Regulatory authorities” in countries which include the European Union, USA, Australia, Canada and Japan.

 

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

For noncompliance with the Act, penalties range from a fine and or imprisonment for not more than five years (Section 67 of the Act).

 

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

There is no national healthcare system in Zimbabwe. There are, however, public hospitals which are subsidized by Government.

 

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

As there is no public healthcare system, this does not apply. There is very little overlap between public and private health care in so far as hospitals are concerned, but both public and private doctors fall under the same governing body (Medical and Dental Practitioners Council and Health Professions Authority) in accordance with the provisions of the Health Professions Act [Chapter 27:19].

 

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

There is no regulatory framework for the price of drugs and devices although some professional bodies have established policies in relation to the pricing of drugs as set out above in paragraph 2.

 

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

Patients pay for drugs and devices themselves. Many Zimbabweans are also members of a medical aid society, and will pay premiums towards the same. Health care, drugs and devises may therefore be subsidized by medical aid societies, with the patient being responsible for the payment of any shortfall.

 

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

Medicines are dispensed by a licensed medical practitioner or pharmacist or any other person licensed by the Authority (Section 17 of the Regulations). Dispensers will ordinarily include their own charges on top of the base price for the drug and device, which shall be used as compensation for their services.

 

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?

The regulations with respect to dispensing is set out in the Medicines and Allied Substances Control Regulations. In terms of these regulations, every person who dispenses a prescription preparation shall ensure that the prescription is not dispensed more than once, unless the prescriber has directed otherwise and in such event, the prescriber’s lawful instructions shall be complied with. At the time of dispensing, or where a prescription preparation has been supplied, on the subsequent receipt of the prescription, there is noted on the prescription the name and address of the supplier and the date on which the prescription is dispensed.

A licensed pharmacist may also dispense drugs from a licensed premise (in accordance with the provisions of Sections 54 and 55 of the Act). The sale of medication without a license is a criminal offence.

In addition, no person must dispense medication for an area to which members of the public have access (Section 59 of the Medicine and Allied Substances Control Regulations, 1991 – hereinafter “the Regulations”).

Doctors and pharmacists will be held to the standard of an expert, and any failure to dispense drugs in a manner in which a reasonable doctor or pharmacist would be considered to be negligence, and could lead to disciplinary or criminal action.