Legal & Regulatory > Portugal > Localization

Want to know more about localization in Portugal? Prepared in association with Cuatrecasas, a leading Iberian law firm, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.

1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies?

Generally, in the pharmaceutical sector, there are no rules and policies requiring localization in Portugal.

However, it is worth noting that market operators that intend to carry out specific activities in the Portuguese territory are required to be authorized and/or registered with the Portuguese Medicines Authority (Infarmed), as follows:

• The manufacture (in whole or in part) of medicinal products, also including the operations of division, packaging, primary or secondary, or fill-finish, is subject to a specific authorization issued by Infarmed.
• The manufacture and distribution of pharmaceutical ingredients (i.e. active substances) is subject to registration with Infarmed.
• The wholesale distribution of medicinal products is subject to a specific authorization issued by Infarmed.
• The importation (i.e. to or from countries outside the EU) of medicinal products is subject to a specific authorization issued by Infarmed.
• The parallel importation (i.e. from countries within the EU) of medicinal products is subject to a specific marketing authorization issued by Infarmed.

In another perspective, in order to obtain a marketing authorization or to conduct a clinical trial in Portugal, market operators shall comply with specific requirements impacted by localization. On the one hand, with respect to marketing authorizations, the applicant shall have its registered office in the EU. Additionally, if results of pharmaceutical, pre-clinical and clinical trials are required for the application and these were conducted outside the EU, the applicant shall submit a declaration stating that the clinical trials meet the ethical requirements set forth in the Portuguese legislation.

On the other hand, with respect to the conduction of clinical trials within national territory and without prejudice to other specific requirements, the sponsor (or its legal representative) is shall have its registered office within the EU.

2. Have there been any recent significant changes involving localization rules? If yes, when did they take place and what did they involve?

No.

3. Is the process of obtaining a marketing authorization impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

In order for a medicinal product to be marketed in Portugal, a marketing authorization from the national authority (Infarmed) is required. Furthermore, foreign authorizations are not automatically recognized, unless the authorization has been issued by the European Commission through the centralized procedure which is then valid within the European Union.

4. Is the pricing process for pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

No, the pricing process is not impacted by localization policies.

5. Is the reimbursement of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

No, the reimbursement is not impacted by localization policies.

6. Is the access to public or public tenders of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

No: the access to public or public tenders of pharmaceutical products is not limited to national or European entities.

7. Are import tariffs, importation and/or exportation permits, trade and/or taxation of pharmaceutical products impacted by localization policies in your country ? If yes, how so?

The importation of medicinal products is impacted by localization rules in the following terms:

• The importation (i.e. to or from countries outside the EU) of medicinal products is subject to a specific authorization issued by Infarmed.
• The parallel importation (i.e. from countries within the EU) of medicinal products is subject to a specific marketing authorization issued by Infarmed.

With respect taxation, the Portuguese legal framework foresees fees specifically applicable on the marketing of medicinal products (currently the fee corresponds to 0.4% on the reference price of the medicinal product).

8. Are there any other incentives or advantages offered by the current local localization rules in your country? If yes, what are they?

Economic or tax incentives to locate companies in Portuguese territory may arise from time to time, and may be national in scope or may originate from European projects/actions (e.g. Portugal 2020 or SIFIDE).

These incentives are usually temporary and vary over time, but are not specifically redirected to the pharmaceutical sector.

9. Are there discussions about the possibility of implementing localization policies in your country? If yes, what are the proposed reforms and when should they come into place?

As far as publicly made available by the Portuguese Government and the Portuguese Parliament, there no discussions in course.