All about marketing, manufacturing, packaging and labeling and advertising of drugs in Portugal. Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, 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?

• Medicinal Products

The marketing of any medicinal products, including new drugs, biologics and over-the-counter medicinal products, is subject to prior marketing authorization from Infarmed.

The authorization shall be granted exclusively based on scientific criteria considering the quality, safety and therapeutic efficacy of the medicinal product.

The marketing authorization process shall be submitted online on Infarmed’s website. All the requested documentation and the communications between the applicant and Infarmed regarding the authorization process shall be only be e-mail.

• Medical Devices

The marketing process for medical devices is substantially different. In fact, the general rule on medical devices is that the manufacturer shall be liable for applying the CE Marking, which is a process that indicates that the medical device complies with European Union legislation on medical devices. However, in some classes of medical devices it may also be necessary to obtain the authorization from Infarmed in order to place the medical device on the market.

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

The generics of medicinal products follow the same authorization procedure to obtain the marketing authorization. However, in the generics case it is not necessary to submit, under the Marketing Authorization procedure, the results and documentation of the preclinical and clinical trials (Please refer to Question 6 of Regulatory, Pricing and Reimbursement Overview).

3. What are the typical fees for marketing approval?

The typical fees for the Marketing Authorization approval of the medicinal products are the following, depending on the type of procedure to be adopted (please refer to Question 4 of Regulatory, Pricing and Reimbursement Overview):

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

Please refer to Question 5 of Regulatory, Pricing and Reimbursement Overview.

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

There is a national pharmacovigilance system managed by Infarmed. The holder of the marketing authorization shall implement and maintain an internal pharmacovigilance system following the same structure and requirements of the national system. The holder of the marketing authorization shall also appoint one person responsible for the pharmacovigilance and make available all the necessary documents for Infarmed regarding these matters.

6. Are foreign marketing authorizations recognized?

Only the marketing authorizations granted from other countries of the European Union. In these cases, the procedure to be adopted is the mutual-recognition which consists on a registration procedure of the medicinal products which is much simpler than the national authorization procedure.

7. Are parallel imports of medicines or devices allowed?

The parallel import of medicinal products is allowed under the European Territory, provided that the following conditions are met:

1. The medicinal product holds a valid marketing authorization from the European Member State of origin;
2. The medicinal product is commercialized in accordance with the Portuguese legislation;
3. The medicinal product shall be similar to the product under consideration (same active substance, form and therapeutic indication);
4. The import does not constitute a risk to public health.

The parallel import shall be authorized by Infarmed in order to verify if the above mention conditions are met.

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?

According to the Portuguese legislation, pharmaceutical companies are now allowed to offer gifts to individual medical practitioners, including giving benefits or objects of up to EUR 60 in value that are relevant for the practice of medicine or pharmacy and/or involve a benefit for the patient.

Sponsorships, consultancy agreements and travel and other benefits related to medical education do not qualify as gifts under the national legislation. However, there are very strict rules governing the offering of these benefits to individual medical practitioners by pharmaceutical companies.

Regarding healthcare organizations, pharmaceutical companies may provide support, either financial or non-financial contributions, to these entities with the purpose of supporting healthcare services or research activities.

However, the healthcare services of the National Health Service, may only receive those gifts and donations from pharmaceutical companies if authorization is granted by Infarmed, in order to ensure that the grant of such support is not deemed to jeopardize the exemption and impartiality.

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

The manufacturing of medicinal products is an activity subject to the prior authorization of Infarmed.

The manufacturing of medical devices is subject to a notification to Infarmed with a 60 days’ notice from the beginning of the manufacturing activity.

Additionally, in case manufacturers are the holders of the manufacturing plants/facilities of medicinal and devices, it is also subject to the general industrial license procedure to be granted by the Minister of Economy.

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?

The local manufacturing practices are in accordance with the guidelines issued by the European Medicines Agency.

11. What is the inspection regime for manufacturing facilities?

Infarmed is entitled to inspect the manufacturing facilities, whenever it deems necessary, and in particular, under a regular inspection and/or also based on any grounds on the breach of the legal requirements.

The competent services from the Minister of Economy may also conduct inspections to the facilities in coordination with Infarmed.

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

No. The inspections shall be conducted by Infarmed employees. However, there may be inspections undertaken at the request of other agencies, including EMA and FDA.

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

The storage, packaging and handling of medicinal products and medical devices shall comply with the good distribution practices of medicinal products set forth in Infarmed Deliberation 047/CD/2015.

The storage, packaging and handling of medical devices products and medical devices shall comply with good distribution practices set forth in Order 256/2016.

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

The labeling of medicinal products shall contain the following information:

1. name of the medicinal product followed by the common name where the product contains only one active substance and if its name is an invented name; where a medicinal product is available in several pharmaceutical forms and/or several strengths, the pharmaceutical form and/or the strength (baby, child or adult as appropriate) must be included in the name of the medicinal product;
2. active substances expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names;
3. the pharmaceutical form and the contents by weight, volume or number of doses of the product;
4. list of those excipients known to have a recognized action or effect whose knowledge is necessary for the use of the product and if the product is injectable, or a topical or eye preparation, all excipients must be stated;
5. the method and, if necessary, the route of administration;
6. a special warning that the medicinal product must be stored out of reach of children;
7. the legal status for supply to the patient;
8. in the case of self-medication, instructions on the use of the medicinal products;
9. mention, if appropriate, potential effects on the ability to drive vehicles or to operate machinery;
10. if applicable, the expression “external use” printed in red;
11. expiry date, including month and year;
12. period of use after reconstitution of the medicinal product or after the first opening of the primary packaging, if applicable;
13. special storage precautions, if any;
14. special precautions for disposal of unused medicinal products or waste materials from medicinal products, if appropriate;
15. the price of the medicinal product;
16. the name and address of the holder of the authorization for placing the medicinal product on the market;
17. the number of the authorization for placing the medicinal product on the market;
18. the manufacturer’s batch number;
19. the expression “free sample”, or “prohibited sale to the public”, if applicable.

The information on the labeling of medical devices depends on the type of medical device. However, all medical devices shall contain the following information:

1. name and address of the manufacturer;
2. the information strictly necessary for the user to be able to identify the device and contents of the packaging;
3. if applicable, the expression “sterile”;
4. if applicable, the batch number;
5. if applicable, the deadline for safe use of the device, expressed in the year and month;
6. if applicable, indication that the device is for single use;
7. if applicable, the expression “custom made device”;
8. for devices intended for clinical investigations, the expression “exclusively for clinical investigation”;
9. special storage or handling conditions;
10. instructions for use;
11. any warning and cautions;
12. manufacturing year;
13. if applicable, sterilization process.

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

The medicinal products reimbursed by the State may include further information whenever deemed necessary.

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

Any items that may lead to an irrational use of the medicinal products.

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

For medicinal products the most important rules and principles on the marketing and advertising are the following:

• The adverting shall encourage the rational use of medicinal products;
• The advertising shall not be misleading;
• The adverting to medicinal products shall be duly identified as such;
• It is forbidden the advertising of a medicinal product that does not hold a marketing authorization;
• Advertising shall be in accordance with the summary of product characteristics;
• It is forbidden to advertise before the general public medicinal products subject to medical prescription.

With the necessary adaptations, the same rules and principles apply to the advertising of medical devices.

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

Medicinal products subject to medical prescription may only be sold or delivered in community pharmacies or hospitals and healthcare establishments. Medicinal products not subject to medical prescription may also be sold in other places rather than pharmacies, such as supermarkets and gas stations, provided that such places are duly authorized before Infarmed.

Regarding medical devices, there are no restrictions to their sale or delivery, except for invitro medical devices for self-diagnosis which may only be sold in pharmacies or other places authorized to sell medicinal products not subject to medical prescription.

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

There are no specific legal rules on advertising on the Internet. Therefore it is subject to the general legal framework applicable to the advertising of medicinal products.

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

Only non-prescription medicinal products may be advertised directly to consumers (Please see Traditional Medicines and OTC Products Questions 2 and 3). Medicinal products may be sold directly to consumers provided that, in the case of medicinal products subject to medical prescription, the prescription is delivered to the pharmacy.

We note that some medicinal products may only be delivered to patients in hospitals or healthcare establishments.

Regarding medical devices, the only prohibition on the direct-to-consumer advertising is regarding the medical devices that for the respective use it requires the mediation and decision of a healthcare professional.

21. How is compliance monitored?

Infarmed is the entity responsible for supervision and compliance with the commercialization of medicinal products, including the advertising of medicinal products and medical products.

The holders of marketing authorizations of medicinal products and other entities responsible for the medicinal products advertising shall send a piece of the advertising to Infarmed within 10 days after its first release.

22. What are the potential penalties for noncompliance?

Please refer to Question 9 of Regulatory, Pricing and Reimbursement Overview.