Traditional Medicines and OTC Products
Want to know more about traditional medicines and OTC products in Portugal? Read on! 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 GBP 99.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
Traditional, herbal, complementary, or alternative medicines are subject to a registration procedure before Infarmed. The registration procedure may be national, based on a mutual recognition procedure or based on a decentralized process.
There are no specific regulations for traditional, herbal, complementary, or alternative medicines. Therefore, such medicines and devices are also regulated by the Medicinal Products Act.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
Yes, provided that the product in question is not subject to medical prescription and that it is not reimbursable by the National Health System.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
Advertising to the public shall not include any information that:
- leads to the conclusion that no medical appointment or surgical procedure is necessary and that induces a certain diagnosis, or treatment by correspondence;
- suggests that the effect of the medicinal product is guaranteed, with no adverse reactions or side effects, with results greater or equivalent to those of another treatment or medicinal product;
- suggests that the person’s normal health condition may be improved by the use of the medicinal product;
- suggests that the person’s normal health condition may be impaired in case the medicinal product is not used (except for vaccination campaigns approved);
- is exclusively or mainly targeted at children;
- refers to a recommendation from scientists, healthcare professional or other persons, who because of their celebrity may encourage the consumption of medicinal products;
- suggests that the medicinal product is food, a cosmetic or personal hygiene product, or any other consumption product;
- suggests that the safety or efficacy of the medicinal product is due to the fact that it is a natural product;
- may lead to an erroneous self-diagnosis through a detailed description or representation of patient history;
- refers in inadequate, alarming or misleading terms to evidence or guarantee of recovery; and
- uses inadequate, alarming or misleading terms, representations of changes in the human body or parts of the human body, caused by diseases or injury or of the action of a medicinal product.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
Over the counter (OTC) medicinal products are governed by the rules of Decree-Law 134/2005, 16 August 2005, amended by Law 51/2014, and subject to the supervision of Infarmed. Regulatory requirements for OTC medications are the same as for prescription drugs, i.e. the Medicinal Products Act.
5. Are there any limitations on locations or channels through which OTC products may be sold?
The distribution and sale of OTC products may be carried out in pharmacies and OTC retailers (i.e. entities duly authorized by Infarmed to sell prescription medicines).
6. What health, advertising, and marketing claims may be made for OTC products?
Please refer to Questions 2 and 3.
7. Can OTC products be marketed or advertised directly to the public?
Yes, it is possible to advertise OTC medicines to the public, if such medicines are not reimbursable by the National Health System. Please refer to Questions 2 and 3.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
Medicinal products shall be subject to medical prescription when they are likely to present a danger either directly or indirectly, even when used correctly, if utilised without medical supervision.
A prescription-only product can be converted to an OTC product when there is an OTC product with similar qualitative and quantitative composition, pharmaceutical form and indications.
The “switching” process can be triggered by an applicant’s request or directly determined by Infarmed.
9. What are the requirements for the importation of either traditional medicines or OTC products?
Please refer to Question 7 of Marketing, Manufacturing, Packaging and Labeling, Advertising.