Traditional Medicines and OTC Products
A brief overview of the situation regarding traditional medicines and OTC products in Spain. Prepared in association with Faus & Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for USD 99.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
Plants traditionally used in Spain for medicinal purposes can be sold to the public without the need for a marketing authorization issued by the AEMPS or the European Medicines Agency. These plants must be offered to the consumer without mentioning any properties for treating or preventing diseases.
Besides, herbal medicines, homeopathic medicines, vaccines and medicinal gases are considered medicinal products, and can only be sold to the public if they have a marketing authorization issued by the AEMPS or the European Medicines Agency. Herbal medicines traditionally used in Spain for medicinal purposes, as well as non-injectable homeopathic medicines that are offered to the public without claiming their value in one or more therapeutic indications, can benefit from a simplified authorization procedure.
The marketing of other alternative products, such as food supplements based on vitamins, minerals and other substances, may be subject to the obligation to communicate their placing on the market to the Spanish competent authorities.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
Traditional, herbal, complementary or alternative products which are not a medicinal product and/or a medical device may be advertised directly to the public provided the requirements described in Question 3 are met.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
Plants traditionally used in Spain for medicinal purposes must be offered to the consumer without mentioning any properties for treating or preventing diseases.
Regarding other traditional, herbal, complementary, or alternative products, Royal Decree 1907/1996 states that such products cannot be advertised in Spain if they:
- Claim properties for preventing, treating or curing diseases.
- Claim slimming properties or against obesity.
- Offer relief or healing certainties.
- Claim to have authorizations, homologations or certificates issued by health authorities of any country.
- Claim their use in healthcare centers or their distribution through pharmacies.
- Are accompanied by healthcare professionals, famous people, or real or suspected patients’ testimonials.
- Suggest that their use or consumption enhance physical, mental, sports or sexual performance.
- Use the term “natural” as a characteristic linked to intended preventive or therapeutic effects.
- Attribute a superfluous nature to medicinal products or medical devices or that are presented as an alternative to such products.
- Attribute a superfluous nature to the intervention of healthcare professionals or that are presented as an alternative to the intervention of said professionals.
These prohibitions do not apply to medicinal products and medical devices that are governed by their specific regulations. Likewise, food products may also claim healthy properties and properties for the prevention of diseases under the terms and with the limitations provided in the European Regulation (EC) No 1924/2006 on nutrition and health claims made on foods.
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 Spanish Law on Medicinal Products as well as Royal Decree 1345/2007, which regulates the authorization and registration procedure for medicinal products industrially manufactured.
Advertising to the public of OTC medicinal products which are not reimbursed in Spain is allowed. Advertisements shall include the following claim: “This product is a medicinal product. Refer to the leaflet. If in doubt, consult your pharmacist”.
In addition, such advertisements 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;
- suggests that its use enhances sports performance;
- refers to alarming, abusing or misleading healing testimonials;
- uses abusively, alarmingly or misleadingly images of alternations of the human body produced by disease injuries, or of the action of the consequences of a medicinal product to the human body; or
- mentions that the medicinal product has obtained the health authority or any other authority.
As regards the advertising of medical devices to the public, the prior authorization from the Spanish regional authorities must be previously obtained. Spanish Law on Medicinal Products expressly prohibits to advertise to the public medical devices which are publicly financed and/or medical devices which are intended to be used or applied exclusively by HCP. Also, according to Royal Decree 1591/2009, it is prohibited to advertise to the public (i) medical devices for self-diagnosis (except for fertility, pregnancy or HIV diagnosis devices), and/or (ii) genetic diagnosis devices.
5. Are there any limitations on locations or channels through which OTC products may be sold?
OTC medicinal products must be sold and delivered by pharmacies only. OTC medical devices may also be sold and delivered to consumers in other stores, such as supermarkets or cosmetic shops. As regards distance selling to the public (e.g. via post) of medicinal products and medical devices, please refer to Questions 18 and 19 on Marketing, Manufacturing, Packaging & Labeling, Advertising.
There are no restrictions in terms of places of sale or distance selling of other OTC products, except for limitations indicated in Question 3.
6. What health, advertising, and marketing claims may be made for OTC products?
Please refer to Chapter 4, Question 3 and 4.
7. Can OTC products be marketed or advertised directly to the public?
Please refer to Question 3 and 4.
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 utilized without medical supervision,
- they are used frequently, and in a very considerable way, under abnormal conditions of use, and this may involve, directly or indirectly, a danger to health;
- contain substances or preparations based on these substances, whose activity or adverse reactions need to be studied in more detail, and
- they are administered parenterally, except in exceptional cases, by medical prescription.
The AEMPS may modify the classification granted to a medicinal product (from prescription-only to OTC and vice versa), when new information is obtained that justifies the re-evaluation of the file. When this happens, a period of one year of data exclusivity is granted from the date in which the authorization of modification is granted.
9. What are the requirements for the importation of either traditional medicines or OTC products?
OTC medicinal products may be imported by the marketing authorization holder in Spain or by a legal entity authorized as importer of medicinal products by the AEMPS. In the event that OTC medicinal products come from EU countries, parallel imports requirements must be followed (please refer to Question 7 on Marketing, Manufacturing, Packaging & Labeling, Advertising).
Besides, to import OTC medical devices from non-EU countries, a specific authorization from the AEMPS is required. Medical devices acquired from other EU countries can freely circulate in Spain. To import cosmetics it is necessary the previous presentation of an affidavit before the AEMPS indicating the contact qualified person details.
As regards importation of OTC products different from the above mentioned, there are no specific rules and general rules on importation and intracommunity trade of goods apply.