Marketing, Manufacturing, Packaging & Labeling, Advertising
The key info on marketing, manufacturing, packaging & labeling and advertising pharmaceuticals in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, 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?
Any new drug, biologic, medical device, over the counter medication and in general medicinal product require a Sanitary Registration.
In order to obtain a Sanitary Registration, the applicant must be properly registered as a laboratory or Drugstore which implies complying with certain requirements including having a Certificate of Good Practice and employing a Chemist.
Furthermore, when requesting a Sanitary Registration, the technical and chemical information of the product must be presented as well as the proposed label of the product.
2. What is the authorization process for the marketing of generic versions of these products?
There is no difference in regulation for the marketing of generics.
3. What are the typical fees for marketing approval?
Typical fees for marketing approval will depend on the product whose Sanitary Registration is being requested and range from $400 to $1,200.
4. What is the period of authorization and the renewal process?
The authorization is valid for 5 years and they can be renewed starting one year before their expiration date.
5. What are the requirements, if any, for post-approval pharmacovigilance?
Security reports must be sent as follows:
- Every 6 months for the first 2 years after the authorization date.
- Annually for the next 3 years.
- Every 5 years starting on year 6.
6. Are foreign marketing authorizations recognized?
There is no foreign marketing authorization that can enable you to commercialize products without a Sanitary Registration obtained in Peru.
However, within the requirements needed for a Sanitary Registration foreign documents such as the Certificate for Free Sale or a Certificate of Good Manufacturing Practices from countries with high sanitary vigilance can be recognized.
7. Are parallel imports of medicines or devices allowed?
Lack of regulation allows for parallel imports provided the importer has the Sanitary Authorization for commercialization of the product.
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?
Regarding such marketing practices, Peruvian regulation forbids any activity that promotes the commercialization, prescription or distribution of pharmaceutical products in the pharmaceutical establishments
Furthermore, in medical establishments medical visitors or other agents of a pharmaceutical company must not have access to medical offices nor interfere with the activities that health professionals carry out with their patients.
Likewise, the sanitary regulation establishes that health professionals may only appear in advertising through the publicity of their testimonies if they are backed by recent, authentic and verifiable experiences.
Finally, the ethical criteria, established by the Pan-American and World Health Organization which state that no incentive must be given to any professional in charge of the prescription or distribution of pharmaceutical products.
9. How is the manufacturing of medicines and devices regulated and by which agencies?
The manufacture of pharmaceutical products and medical devices are regulated by the provisions of Law N° 29459, Law on pharmaceutical products, medical devices and sanitary products and its regulations approved by Supreme Decrees No. 014-2011-SA and No. 016-2011-SA, and complementary rules. For manufacturing, the Sanitary Registration of the product or device is required. Manufacturing can be done directly, if the owner is a duly authorized laboratory at the local level or the manufacturing can be ordered to another national or foreign laboratory, which must comply with the regulatory conditions, whose point has been developed in question 3 of Regulatory, Pricing and Reimbursement.
The authority in charge of granting the Sanitary Registration of the product or device, the Sanitary Authorization of operation of the laboratory as well as the certificates of good practices is DIGEMID by order of the Ministry of Health.
10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the U.S. Food & Drug Administration and/or the European Medicines Agency?
Local manufacturing requirements are compatible with the GMPs as defined by the FDA according to the List of Documents considered equivalent to the Certificate of Good Practices.
11. What is the inspection regime for manufacturing facilities?
There are 2 types of inspection.
First, to obtain the Sanitary Authorization to function as a manufacturing facility a previous inspection by DIGEMID is required, in which compliance with the Good Manufacturing, Laboratories and Storage Practices is verified.
A resolution, granting or rejecting authorization is issued in the next 30 days after the procedure starts.
When the manufacturing facilities are working, inspections are conducted by Chemists under the directions of DIGEMID. In order to enter the pharmaceutical establishment, they must have, in addition to their ID, a presentation letter subscribed by the incumbent of DIGEMID.
During the inspection, the inspectors can request the documentation regarding the fabrication procedures. They are also able to perform all kinds of controls, seizure of products, verification. The seizure of products can be done with the purpose of verification that the conditions over which authorization was granted is fulfilled.
The seizure of products may occur at any stage of the fabrication process.
Whoever is present at the establishment must allow the inspection to be conducted properly.
12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?
Manufacturing facilities are open for foreign inspectors provided a cooperation agreement has been reached with a foreign regulatory body.
13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
Regarding packaging, it must be innocuous and adequately guarantee that the product or device will maintain the composition, quality and quantity declared by the manufacturer.
Regarding storage, the establishments must comply with the regulation for Good Storage Practices.
Regarding the handling of medicines and devices, they must be conducted in a laboratory with the appropriate authorizations.
14. What information must be included in medicine and device labeling?
The labels of pharmaceutical products and medical devices must include the following:
- Pharmaceutical specialty and Ingredients
- Pharmaceutical Form and content (volume or doses)
- List of excipients whereof there is a recognized effect
- Route of administration
- Warning and Precautions
- Warning to maintain away from children
- Expiration date
- Storage Conditions
- Commercialization Conditions
- Technical Director name
- Name and Country of the Lab that manufactures the product or device
- Contact information of the holder of the Sanitary Registration
- Contact information of the importer.
- Sanitary Registration Number (RS N°…)
- Badge Number
15. What additional information may be included in labeling and packaging?
Only information approved in the Sanitary Registration may be included.
16. What items may not be included in labeling and packaging?
Affirmations guaranteeing that the product might cure you from a disease cannot be advertised in the label or packaging, nor can information that may induce auto medication in the consumers.
Furthermore, tags cannot be attached to the packaging to correct or add information except those that would indicate information regarding the importer, Technical Director or any information authorized by DIGEMID
Finally, information not consigned in the Sanitary Registration may not be consigned
17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?
The advertising for pharmaceutical products and devices must include the main warnings and precautions authorized in the Sanitary Registration and the adequate doses. Furthermore, exaggerations or inaccuracies that might mislead the consumer cannot be included.
18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?
Pharmaceutical products and devices may be sold in any establishment that has been granted a Sanitary Authorization. The only exception for this authorization is the commercialization of products with very low sanitary risk.
19. What are the restrictions and requirements for electronic marketing and advertising via email, by Internet, social media, and other channels?
Advertising by electronic means must include the main warnings and precautions authorized in the Sanitary Registration and the adequate doses. Furthermore, exaggerations or inaccuracies that might mislead the consumer cannot be included.
Finally, it is worth mentioning that the main warnings and precautions must be presented in a clear way that is proportional to the duration of the advertising. (i.e. in a radio advertising they cannot be spoken faster than the rest of ad)
Regarding commercialization, it is authorized for products and medical devices both with and without a prescription with the exception of narcotics, psychotropic and other that are subjected to sanitary control. It must take place in vehicles or containers that are properly conditioned to comply with the regulation of Good Storage, Distribution and Transport Practices. Good Distribution Practices must also be ensured.
20. May medicines and devices be advertised or sold directly to consumers?
Medicines and devices may be advertised and sold directly to consumers as long as they do not require a medical prescription.
21. How is compliance monitored?
Every batch of products entering the market is subject to a quality control. Furthermore, local health authorities may inspect establishment that store, distribute, commercialize pharmaceutical products and confiscate the products for analysis in any step of the fabrication, storage, distribution or commercialization process.
22. What are the potential penalties for noncompliance?
Confiscations can also be made at bonded warehouses for imported products.
Penalties for noncompliance go as follow:
- Small fines
- Suspension of the Technical Director
- Bigger fines
- Cancelation of the Certificate for Good Practices
- Suspension of the Sanitary Registration
- Cancelation of the Sanitary Registration
- Temporary suspension of the fabrication or commercialization activities
- Temporal closure of part or all facilities
- Definitive closure of the establishment or its facilities.
- Confiscation of products, devices, materials and/or machinery