The Pharma Legal Handbook: Venezuela

The legal framework for cannabinoid drugs, medicinal cannabis and opioid drugs in Venezuelan Pharma. Prepared in association with Hoet Pelaez Castillo & Duque (HPCD), a leading law firm in Venezuela, this is an extract from The Pharma Legal Handbook:Venezuela, available to purchase here for USD 99.

 

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

No.

 

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

The National Unique Registry of Chemicals Operators. Meanwhile, they are competent as criminal investigation police authorities under the direction of the Public Ministry: The National Armed Forces, the Corps of Scientific, Criminal and Criminal Investigations and the Maritime Police. (Art. 121, 127, 128 and 129 Organic Law against Illicit Trafficking and Consumption of Narcotic and Psychotropic Substances.)

 

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

There are no formal proposals on this issue. It does not seem that any significant change is approaching in the short term.

 

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

No.

 

Medicinal Cannabis

5. Is Medicinal Cannabis authorized in the country?

No.

 

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

The National Unique Registry of Chemicals Operators. Meanwhile, they are competent as criminal investigation police authorities under the direction of the Public Ministry: The National Armed Forces, the Corps of Scientific, Criminal and Criminal Investigations and the Maritime Police.

 

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

We do not advance any significant progress, regarding the regulation of Medicinal Cannabis.

 

Opioid Drugs

8. Are Opioid Drugs authorized in your country?

Yes, they are allowed for medicinal use and in a controlled manner.

 

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

The Ministry of Health, National Drug Council (CONMED), Pharmaceutical Products Review Board and the National Registry of Chemicals Operators.

 

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

We do not have a specific regulatory framework for opioid drugs. These are regulated through the Drug Law, the Official Drug List and the Fair Price Law.

 

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

Opioid anaesthetics

• 1-02-0307-02-10-03 Fentanyl, 0.05mg / ml, vial or vial, 10ml, I.V. VEN-M: V.

Opioid analgesics

Natural Opium Alkaloids

• 01-01-0840-31-10-3E Morphine sulphate, 15mg, capsules or tablets, V.O. (Narcotics Control). * VEN

M: V, Restricted use: Oncology, Hematology, Orthopedics, and Pain Clinic.

• 1-02-0668-01-10-03 Morphine hydrochloride or sulphate, 10mg / ml, ampoule, calibrated syringe or vial, 1ml, S.C.; I.M.; I.V. (Narcotics Control).

(Official Drug List No. 25787 Official Digital Gazette, Wednesday, May 9, 2007.)

 

12. Who can prescribe Opioid Drugs?

“Medicines with an optional prescription will only be prescribed by medical professionals, dentists and veterinary doctors. Those must be qualified for the exercise of the profession and duly registered before the respective Ministry.”

(Article 35. Medication Law). In the case of some opioids, they can only be prescribed by: Oncology, Hematology, Orthopedics, and Pain Clinic.

 

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

There is a list of doctors and specialists in the country. However, we do not have an independent record of which of these doctors are authorized to prescribe opioids.

 

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

Pharmaceutical Laboratories, drug stores, representative houses and pharmacies; These have different functions.

 

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

No.

 

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

We are not aware of upcoming reforms or changes in the regulation of this substance.

 

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Keen to learn more about regulatory reforms in Venezuelan Pharma? Read on! Prepared in association with Hoet Pelaez Castillo & Duque (HPCD), a leading law firm in Venezuela, this is an extract from The Pharma Legal Handbook:Venezuela, available to purchase here for USD 99.

 

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

We are not aware of any reform or proposed change within the health system.

 

2. When are they likely to come into force?

We do not anticipate any change in the short or medium term.

 

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An insight into patents & trademarks in Venezuelan Pharma. Prepared in association with Hoet Pelaez Castillo & Duque (HPCD), a leading law firm in Venezuela, this is an extract from The Pharma Legal Handbook:Venezuela, available to purchase here for USD 99.

 

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

The basic requirements for a patent application consist of: (Art. 59 Industrial Property Law)

A. Submit the application and a copy of it to the Autonomous Intellectual Property Service. It must include:

• Name, address and nationality of the inventor.
• Name and address of the agent, when the request is by proxy.
• The applicant must really be the inventor or discoverer of the good to be patented.
• The object of the patent has not been used in Venezuela, under any circumstances.
• The originality.
• The kind of patent requested.
• Number, date and origin of the foreign patent or source of necessary information in the case of ignorance of the data, when referring to an introduction patent.

The application must be accompanied with:

• A duplicate report, in Spanish, which clearly describes the object on which the patent rests with complete and exact specification of the operation and construction method, make or combine the corresponding machine, handwriting, composition of matter, procedure, improvement, model or industrial drawings.
• Drawings and samples of the object.
• Clisé of the model or industrial drawing (should not exceed 8 * 10 centimeters);
• Certified copy, legalized and translated into Spanish of the patent letters of the country of origin. In the event that it has been previously patented abroad.
• The power legally granted, in the event that the request is by proxy.

It must be verified that the foreign patent is in force and the time remaining to expire for its expiration in the country of origin. As long as it has been previously patented in another country.

The basic requirements for the application of a trademark consist of: (Art. 71 Industrial Property Law)

A. Submit the application and a copy of it to the Autonomous Intellectual Property Service. It must include:

• Name, address and nationality of the applicant and the agent when it is done through a proxy.
• Full description of the brand, clearly and precisely on the essential part or the distinctive sign.
• The manuscripts, products, objects and articles that distinguish the brand and its respective class. In addition, if these are of national or foreign production and, in the latter case, if it is a registered trademark in the country of origin.
• Time in which the brand has been in use, if applicable.
• If the brand is applied to manufacturing or extractive industries, objects of a trade or agricultural products.
• That the brand has no similarity with another analog already registered, for articles of the same class or similar; so that it generates confusion or deceit to the public.

The application must be accompanied with:

• Five fascimiles of the brand and the cliche or photogravure of it (the dimensions cannot exceed 8 * 10 centimeters). It will not be necessary in the event that the mark consists only of words;
• The power legally granted in the event that the request is made by proxy.

 

2. What agencies or bodies regulate patents and trademarks?

Autonomous Intellectual Property Service (SAPI).

 

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

The following may be the subject of a patent: (Art.14 Industrial Property Law)

• All new, defined and useful product.
• Any new machine, tool, instrument or apparatus for industrial use or medicinal, technical or scientific application.
• The parts or features through which greater economy or perfection is achieved in the products or results.
• New procedures for the preparation of materials or objects for industrial or commercial use, chemical products and new methods of processing, extraction and separation of natural substances.
• The improvements, reforms or modifications introduced in previously known things.
• All new model or drawing for industrial use.
• Another invention or discovery suitable for industrial application.
• That invention, improvement, model or industrial design patented abroad but not disclosed, patented or executed in Venezuela.

This list is not taxative. In reality, the result of the inventive effort of human ingenuity is patentable; unless it consists of an exception established by law.

They are not patentable: (Art. 15 Industrial Property Law)

• Drinks and food items, whether for human or animal consumption. Medicines of all species. Also, medicinal pharmaceutical preparations, reactions and chemical combinations.
• The systems, combinations or financial, speculative, commercial, advertising or simple control or control plans.
• The simple use or use of natural substances or forces.
• The use of goods already known or used for certain purposes and simple changes or variations in form, dimension or material.
• Work modalities or manufacturing secrets.
• Simply theoretical or speculative inventions. That is to say that those where it is not possible to point out and demonstrate its practicality and its industrial application definitively.
• Inventions contrary to national laws, health, public order, morality, good customs and state security;
• The juxtaposition of elements already patented or in the public domain; unless they lose their characteristic function.
• The inventions that have been made known in the country for being published or disseminated in printed works or other form. In addition, those in the public domain due to their execution, sale or advertising inside or outside the country, previous to the patent application.

Any name or distinctive sign in which there is a personal interest may be registered, as if it were a trade name; although this is not commercial, by way of exception.

They may not register as trademarks: (Art. 33 Industrial Property Law)

• Those that suggest immoral ideas or serve to distinguish immoral objects or merchandise from prohibited production or commerce and those used in illegal business or on a harmful item.
• Flags, shields or badges of the Republic, of the states, municipalities or public entities. In addition, those from foreign nations, except when their use is duly authorized.
• Signs, emblems and badges of the Red Cross and similar entities.
• Geographical names, as indicators of the place of origin.
• The shape and color that is given to the articles or products by the manufacturer, or colors or combinations of colors by themselves.
• Geometric figures without novelty.
• Cartoons, portraits, drawings or expressions that tend to ridicule ideas, people or objects worthy of respect and consideration.
• The terms and phrases that are commonly used and expressions used to indicate the genus or species.
• Full name or surname of a natural person.
• The brand similar graphically and phonetically to another previously registered.
• The one that is confusing with another previously registered trademark or may induce error by indicating false origin or quality.
• The merely descriptive trade names.
• Commercial slogans that contain allusions to similar products or brands or that may harm them.

 

4. How can patents and trademarks be revoked?

Patents are without effect: (Art. 17. Industrial Property Law)

1. By the ruling of a competent court, to annul it for harming a better right of third parties.
2. When the exploitation or export of the invention ceases or is stopped for two years from the date of issue, except in the event of an accident or force majeure.
3. Due to lack of payment of the annuities.
4. For the express resignation of the inventor.
5. For being objected by the holder of the corresponding foreign patent requesting its registration within the country within the established period.saw. By the Minister of Development on the grounds that obtaining the patent is in contravention of the Industrial Property Law. Currently, it is called the Ministry of People’s Power of Planning.

The marks are without effect: (Art. 36. Industrial Property Law)

1. At the wish of the interested party.
2. When the deadline has expired without requesting renewal.
3. By the judgement of the competent court when they are considered harmful for a better right of third parties or when it is declared, for reasons of validity, that should never have been granted.
4. When it expires for not making use for two consecutive years.

 

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

Patented goods abroad can be patented, in the same way, in Venezuela; as long as the legal requirements are met. In addition, the one who owns a patent abroad will have priority to obtain it within our country, within the twelve months following the date of the foreign patent. Meanwhile, trademark registrations will have priority within six months following the date of registration of the foreign brand.

 

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

The Antitrust Law is responsible for regulating economic competition. In addition, behaviors that constitute unfair competition are sanctioned.

 

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

There is a restriction to patent medications of all species, pharmaceutical preparations and chemical preparations, reactions and combinations. As for the brands, a restriction is proposed for those of prohibited production or trade and those used in illegal businesses or on a harmful item.

The Organic Law Against Illicit Trafficking and Consumption of Narcotic and Psychotropic Substances establishes those substances as prohibited.

 

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

No.

 

Also from this Legal Handbook

The ins and outs of product liability in Venezuelan Pharma. Prepared in association with Hoet Pelaez Castillo & Duque (HPCD), a leading law firm in Venezuela, this is an extract from The Pharma Legal Handbook:Venezuela, available to purchase here for USD 99.

 

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

Civil, criminal and administrative liability.

 

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

The 3 types of responsibilities apply.

 

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

Potential liability may also extend to corporate executives, employees and representatives.

 

4. How can a liability claim be brought?

The way in which a claim of liability must be initiated will depend on whether it refers to civil, criminal or administrative liability.

 

5. What defences are available?

The defense will depend on the type of responsibility attributed. Our constitutional text establishes the principle of due process applicable to all judicial and administrative proceedings. In addition to, it affirms the inviolability of the right to defense and legal assistance.

 

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Traditional medicines and OTC products in Venezuelan Pharma – a comprehensive legal overview. Prepared in association with Hoet Pelaez Castillo & Duque (HPCD), a leading law firm in Venezuela, this is an extract from The Pharma Legal Handbook:Venezuela, available to purchase here for USD 99.

 

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

The Constitution of Venezuela recognizes the practice of traditional medicine in indigenous peoples and communities. Alternative medicine is not regulated.

 

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

Yes.

 

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

The promotion and publicity of the traditional and alternative medicine must be carried out in accordance with the standards established by the Pharmaceutical Products Review Board.

The promotion must be compatible with the National Health Policy and adjusted to the ethical criteria for the promotion of medicines, which include: offering truthful information, avoiding any type of deception or exaggeration; be carried out within the ethical-sanitary criteria; and induce the rational use of the product.

 

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

The Ministry of Popular Power for Health (MPPS) is the governing body of the health sector in Venezuela, is responsible for the regulation, formulation, design, evaluation, control and monitoring of health, social development and health policies, programs and plans; Applicable to OTC products.

 

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

The Autonomous Health Comptroller Service, attached to the Ministry of Popular Power for Health, establishes the requirements for obtaining health perisology; as well as the minimum sanitary conditions necessary for the distribution or commercialization of OTC products with therapeutic activity; These requirements are established in Administrative Providence No. 236- 2016 of the aforementioned Autonomous Service.

 

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

The promotion and publicity of OTC Drugs should be carried out in accordance with the standards established by the Pharmaceutical Products Review Board. The promotion must be compatible with the National Health Policy and adjusted to the following ethical criteria for the promotion of medicines: Offer truthful information, avoiding any type of deception or exaggeration; Be carried out within the ethical-sanitary criteria; and induce the rational use of the product.

 

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

Yes, as long as they comply with the standards established by the Pharmaceutical Products Review Board.

 

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

The prescription of OTC products must be carried out in a mandatory manner, indicating their concentration, pharmaceutical form, route of administration and dose per dosage unit, using prescriptions or medical recipes, as established in the Official Gazette of the Bolivarian Republic of Venezuela N °. 40,131 dated 03/19/2013.

 

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

N/A.

 

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Key legal info on marketing, manufacturing, packaging & labeling, advertising in Venezuelan Pharma. Prepared in association with Hoet Pelaez Castillo & Duque (HPCD), a leading law firm in Venezuela, this is an extract from The Pharma Legal Handbook:Venezuela, 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?

To request the authorization of a clinical protocol of a Pharmaceutical Specialty, the applicant must complete the form “F-RCDM-011 Request for Authorization of Clinical Protocols for Pharmaceutical Specialties” as indicated in the respective Instructions, submit the required receipts and pay the corresponding fee.

Once the application is accepted, it will be evaluated by the competent Unit and in case of conformity, it will be authorized by the Pharmaceutical Products Review Board, as established in the Medicines Law.

If during the clinical study of the Pharmaceutical Specialty a serious adverse event occurs in any patient, it must be reported using the form F-RCDM-014 Report of National Serious Adverse Events in Clinical Studies of Pharmaceutical Specialties as indicated in the respective Instructions.

Once the respective clinical protocol is authorized, it will be subject to inspections, at which time the Representative of the product in the country must pay the respective fee, as established in the Official Gazette of the Bolivarian Republic of Venezuela No. 39.819 from 12/13/2011.

 

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

The authorization process for the marketing of generic versions is the same indicated in the previous answer.

 

3. What are the typical fees for marketing approval?

The Sanitary Registration Fee for Pharmaceutical Products in Venezuela varies according to the product category: The fee must be paid to the National Institute of Hygiene. The amount to be paid will depend on the category of the Pharmaceutical Specialty to be Registered, according to the Official Gazette of the Bolivarian Republic of Venezuela No. 39,819 of 12/13/2011. Also consider the Regulations for the Payment of the Services of the INH” RR”, Circular No. P-178/2012 dated 10/02/2012.

 

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

The authorization and renewal period will depend on the integral evaluation of the product by the respective technical units, and by the Pharmaceutical Products Review Board.

If the opinion is satisfactory, the respective Health Registry Office is issued, as well as the Marketing Conditions authorized for the registered pharmaceutical specialty.

 

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

Pharmacovigilance is a simple and economical system, in which the main role of the healthcare professional is the voluntary notification of suspected adverse drug reactions; It is also an activity shared between the regulatory authority, health professionals, industry and the community (patients / consumers). For it, the reports are made through the online reporting system available on the INHRR website, which is an online adaptation of the form internationally known as the yellow sheet. In the case of the Pharmaceutical Industry, the mechanism is fulfilled through a form specifically designed for this purpose, which is subsequently sent to CENAVIF through the email cenavif.ea@inhrr.gob.ve.

 

6. Are foreign marketing authorizations recognized?

No.

 

7. Are parallel imports of medicines or devices allowed?

No.

 

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?

The promotion and advertising in the form of financial or material benefits to health professionals or anyone in charge of dispatching medicines is prohibited, as it could lead to a prescription or induced sale of medicines. In addition, the marketing of the pharmaceutical product must be in accordance to the National Sanitary Policy, and following the ethic principles of providing factual information, avoiding any deceit or exaggeration, as well as promoting the normal use of the product.

 

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

The manufacture of medicines and devices in Venezuela is regulated by the Medicines Law; This Law regulates everything related to pharmaceutical policy in order to ensure the availability of effective, safe and quality medicines, as well as their accessibility and rational use to all sectors of the population within the framework of a national health policy.

 

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)?

No.

 

11. What is the inspection regime for manufacturing facilities?

The inspection regime for manufacturing facilities is in charge of the Autonomous Sanitary Comptroller Service which has among its competences: Registration, analysis, inspection, surveillance and control over the processes of production, storage, handling, transport of fixed assets and human consumption, and about materials, equipment, devices and industries, health-related activities.

 

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

No.

 

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

Requirements for the storage, packaging and handling of medicines and devices and their components can be found in detail in the following link: http://www.sacs.gob.ve/site/index.php/advanced-stuff/direccion-de-regula- cion-y-control-de-materiales-equipos-establecimientos-y-profesiones-de-sa lud/2017-04-21-02-14-58.

 

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

Medications must be labelled. At least one International Common Designation (INN) or generic name, trade name, lot number, pharmaceutical form, concentration, manufacturer’s name, quantity contained in the package, the conditions of each package must be included in each package storage, processing date and expiration date. If deemed convenient, the Pharmaceutical Service may request an analysis of these to the competent authorities.

 

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

The package must include at least the following information:

1. – Generic name of the medicine.
2. – Commercial name.
3. – Pharmaceutical form.
4. – Concentration.
5. – Dose to be packaged.
6. – Number of doses to be renewed.
7. – Laboratory manufacturer.
8. – Date of elaboration of the laboratory.
9. – Batch number of the original medicine.
10. – Packaging batch No. or internal control No.
11. – Expiration date of the original medication.
12. – Expiration date of the packaged or repackaged medicine.
13. – Name and signature of the person in charge of the process.
14. – Name and signature of the responsible pharmacist.

Each packaged medicine must be identified with a label containing the following information:

1. – Name of the Institution.
2. – Name of the Pharmaceutical Service.
3. – Generic name of the medicine.
4. – Commercial name.
5. – Pharmaceutical form.
6. – Concentration.
7. – Dose.
8. – Expiration date.
9. – Internal control number or batch number of the packaging or repackaging

 

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

It is prohibited to use information and promotional material in the text of labels, packaging or internal leaflets, which accompany the medicine and must strictly comply to the text approved by the Ministry of Health and Social Development.

 

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

The promotion and publicity of medicines must be carried out in accordance with the standards established by the Pharmaceutical Products Review Board. The promotion must be compatible with the National Health Policy and adjusted to the following ethical criteria for the promotion of medicines: Offer truthful information, avoiding any kind of deception or exaggeration; Be carried out within the ethical-sanitary criteria; & Induce the rational use of the medicine.

 

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

Medications and devices can be sold or delivered to drug stores, pharmacies and establishments authorized for that purpose by the National Government. Establishments that provide medications and other items in the field to the public can sell all kinds of medicinal preparations, official and masterly made by a pharmacist. Medications cannot be sold or delivered by mail.

 

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

In practice, there are currently no restrictions for the marketing and sale of medicines and medical supplies in the country, via email, internet, social networks etc., due to the great shortage of these products.

 

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

Yes.

 

21. How is compliance monitored?

The monitoring is carried out through the National Institute of Hygiene.

 

22. What are the potential penalties for noncompliance?

The Law on the Exercise of Pharmacy and the Law on Medicines contain provisions that punish illegal sales of medicines and medical supplies. The Medicines Law establishes penalties from 6 months to 3 years, and penalties equivalent to 360 tax units for those who alter the quantity, dose or composition of a medicine or for those who falsify it. It also states that in the event of damage to a third party, penalties established in the Criminal Code will also be applied.

 

Also from this Legal Handbook

The key facts about preclinical and clinical trial requirements in Venezuelan Pharma. Prepared in association with Hoet Pelaez Castillo & Duque (HPCD), a leading law firm in Venezuela, this is an extract from The Pharma Legal Handbook:Venezuela, 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?

Yes.

 

2. How are clinical trials funded?

Clinical trials are funded by those interested in obtaining the product’s marketing permit.

 

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

Clinical trial protocols must include:

1. Protocol title, protocol identification number and date. Any amendment must also have a number and date;
2. Research phase;
3. Name and address of the sponsor and the monitor;
4. Name and title of the person authorized by the sponsor to sign the protocol and amendments
5. Name, title, address and number of the expert’s doctors or dentists of the trial sponsor;
6. Name and curriculum vitae of the researcher responsible for the carrying out test and the address of the test location;
7. Name, curriculum vitae, address and telephone number of the qualified physician or dentist responsible for decisions medical or dental related to the test site (if It does not match the investigator);
8. Name and address of the clinical laboratory and others medical and / or technical departments and / or institutions involved.
9. Summary of the protocol.

The National Institute of Hygiene is the governmental entity that approves the protocol.

 

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

The consent of the informed party is a process by which a subject voluntarily confirms his/her desire to participate in a clinical trial, after having been adequately and in detail informed about all the relevant aspects of the investigation and that are of their interest for the taking of That decision.

Prior to the participation of the parties in a clinical trial, their voluntary consent must be obtained from each of them or by their respective legal representatives after having been informed in detail of all the aspects that are relevant to said decision.

The participant’s consent will be documented by means of a written, signed and dated form.

Any information or written document used for the consent process must be previously approved by the Ethics Committee.

The form for the written consent of the informed subject and any other written information to be delivered to the subjects must be reviewed when new information arises that could be relevant to their consent. Said information must have the prior approval of the Ethics Committee and be communicated in due course to the subject or to the legally accepted representative. The communication of this information must be documented.

Neither the investigator nor the trial staff shall force, coerce or unduly influence a subject to participate or continue their participation in an essay.

The investigator or his designee must fully inform the subject or his legally accepted representative of all relevant aspects of the trial.

The language used in the written and verbal information about the essay should be practical and not technical and the subject, his legally accepted representative and the impartial witness, when appropriate, should understand it. In case that the subject’s language was not currently used in the country or community, the information to the subject and the consent must be provided in their language.

Before obtaining the informed subject’s consent, the investigator or his designee must give the subject or his legally accepted representative enough time and opportunity to ask about the details of the essay and to decide whether or not to participate in it.

All questions about the essay should be answered to the satisfaction of the subject or his legally accepted representative.

Before a subject participates in the trial, the consent form must be signed and dated by the subject himself or by his legally accepted representative and by the person who led the discussion of consent.

 

5. May participants in clinical trials be compensated?

Yes.

 

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

The consent of the participant must include a compensation clause indicating that, with the signature of this, the subject is automatically protected by an insurance policy and / or a written record in which the sponsor declares that he assumes the responsibility of covering all medical expenses that occur as a result of any damage or injury related to the trial.

 

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All legal aspects surrounding regulatory, pricing and reimbursement in Venezuelan Pharma. Prepared in association with Hoet Pelaez Castillo & Duque (HPCD), a leading law firm in Venezuela, this is an extract from The Pharma Legal Handbook:Venezuela, 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 authority is the National Institute of Hygiene.

 

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

Organic Law of Health and Resolution NUMBER-0010-9921 of the MINISTRY OF HEALTH AND SOCIAL DEVELOPMENT dated September 1999.

 

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

To obtain a Health Registry, the interested party must meet the following requirements:

a. Appoint a legal representative, professional in the area of Health.
b. Submit an application form designed by the Ministry of People’s Power for Health, accompanied by a copy of the following collections:

1. Articles of Incorporation and Bylaws with their modifications, if any;
2. Industry and Commerce Patent of the corresponding applicant;
3. Authenticated power of attorney document granted to the legal person to processing application;
4. Academic title of the processing Health professional.

c. Submit a list of products subject to commercial exploitation;
d. A report of the inspection of the premises that will serve as storage of the products, executed by the Ministry of Health and Social Development.

 

4. What are the approximate fees for each authorization?

Approximately 200 to 400 USD, depending on the procedure and the authorization request.

 

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

The validity of the Registration / authorization varies between 5 and 7 years depending on the application. The renewal must be requested at least 6 months prior to the expiration of the registration / authorization, using the form F-RCDM-007.

 

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

The authorization process is the same in both cases, only the required documentation varies.

 

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

There are specific instructions for each of the mentioned combinations.

 

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?

Once the sanitary registration has been granted to the specialty pharmaceutical, the Representative of the product in the country (holder of the sanitary registry), must notify the National Institute of Hygiene, the beginning of the commercialization, request the collection of samples of the first batch and pay the respective rate.

There is a Division of Drug Control, which annually carries out a program of controlling products marketed in Venezuela, in accordance with the criteria established in the respective procedure, for which the respective samples will be collected.

This regulatory regime is not comparable with that from the USA or the European.

 

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

The failure in the notification of the beginning of commercialization or the non-commercialization of the product in the time established in the current regulations, leads to the cancellation of the respective sanitary registration.

 

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

The Constitution of Venezuela guarantees the right to Health. For this purpose, the State will create, exercise the rectory and manage a National Public Health System, of an intersectoral, decentralized and participatory nature, integrated into the social security system, governed by the principles of gratuity, universality, integrity, equity, social integration and solidarity.

The Ministry of the People’s Power for Health (MPPS) is the governing body of the health sector in Venezuela, that is responsible for the regulation, formulation, design, evaluation, control and monitoring of health, social development and health policies, programs and plans; the integration of the sources of financing and allocation of resources of the National Public Health System; comprehensive health care to all sectors of the population, especially low-income ones; and the promotion of citizen participation.

The financing of the National Public Health System is mandatory for the State, through the integration of fiscal resources and mandatory social security contributions, among others.

Another public provider of Health Service is the Venezuelan Institute of Social Security (IVSS).

 

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

The government Health system works very poorly compared to the private health system.

 

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

There are currently no effective government controls to regulate the prices of medications and medical devices.

 

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

In general, the costs of medications (drugs) and devices must be paid by patients. The role of the government and private entities in the payment of these items is very limited due to the high inflation rates that exist in Venezuela.

 

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

Most of the time, medications and devices are distributed to patients by the private sector that pays attention to the patient; When the patient goes to a public organization in the vast majority of cases, it must be the same patient who provides the supplies and / or assumes their cost.

 

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 professional and legal responsibilities of the suppliers of drugs and medical devices in Venezuela are established by:

• The National Constitution;
• The Organic Health Law;
• The Organic Drug Law;
• The Medication Law;
• The Law of Pharmacy and its Regulation;
• Civil and Criminal Codes.