Marketing, Manufacturing, Packaging & Labeling, Advertising
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 firstname.lastname@example.org.
6. Are foreign marketing authorizations recognized?
7. Are parallel imports of medicines or devices allowed?
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)?
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?
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:
- – Generic name of the medicine.
- – Commercial name.
- – Pharmaceutical form.
- – Concentration.
- – Dose to be packaged.
- – Number of doses to be renewed.
- – Laboratory manufacturer.
- – Date of elaboration of the laboratory.
- – Batch number of the original medicine.
- – Packaging batch No. or internal control No.
- – Expiration date of the original medication.
- – Expiration date of the packaged or repackaged medicine.
- – Name and signature of the person in charge of the process.
- – Name and signature of the responsible pharmacist.
Each packaged medicine must be identified with a label containing the following information:
- – Name of the Institution.
- – Name of the Pharmaceutical Service.
- – Generic name of the medicine.
- – Commercial name.
- – Pharmaceutical form.
- – Concentration.
- – Dose.
- – Expiration date.
- – 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?
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.