Free Drug Samples in Spain: limitations and authorisation process

In Spain, the regulation of free drug samples is subject to a series of national and European rules to ensure the responsible and controlled use of these practices. It is important to note that this activity is part of the promotion of marketed medicines, and subsequently, before promotion, a medicine has to be commercialized and ready to be used by patients with all guarantees.

What is a free drug sample?

It is a sample given without cost to a health professional qualified to prescribe the product. It will be no larger than the smallest presentation of the medicine on the Spanish market.

•  It is part of a promotional activity.
• Only free samples are allowed for those medicines for which the formulation is novel in the therapeutic-related field.
• Requires health professionals to know about the novelty.
• Notwithstanding the above, when a new medicine is marketed as an extension of an existing product, samples of that new medicine can be provided as above.

For example, extensions can be new pharmacological properties, target populations, or therapeutic indications.

Legislation

The principal regulations governing the distribution and delivery of free drug samples are as follows:

1. Law 29/2006, of July 26, on the Guarantees and Rational Use of Medicines and Health Products.
2. Royal Decree 1416/1994, of June 25, on the Advertising of Medicines. This Royal Decree regulates the advertising of medicines and sets restrictions on free samples.
3. Code of Good Practices of the Pharmaceutical Industry: This code establishes that:

Provisions

• Samples shall be identical to the smallest presentation of the marketed medicinal product.
• Limited quantity: no more than 10 samples of a particular medicine may be provided to an individual health professional during a year, no more than 2 years since the date of authorisation of the medicine.
• Not permitted for any medicine which contains a substance listed as Narcotic Drugs and Psychotropic Substances
• Free samples can only be delivered to healthcare professionals to evaluate the medicines: doctors, dentists, and pharmacists for evaluation and not to the general public.
• Registration and distribution control: Pharmaceutical companies must maintain strict control over the samples they distribute, recording the quantity, the recipient, and the purpose of the delivery. Samples must be delivered directly to healthcare professionals and not through intermediaries.
• Conditions of delivery: Samples must be delivered in proper conditions, such as maintaining the original packaging and providing clear information about the drug’s characteristics.
• Prohibition of Dispensing to Patients

Request of free drug samples: Spanish Medicines Agency

Free drug sample request requires authorisation by the Spanish Medicines Agency (AEMPS). This process requires expertise and credentials to the local portal.

Conclusion

In summary, the authorisation and subsequent distribution of free drug samples in Spain are highly regulated to ensure their proper and rational use, prevent misuse and misleading advertising, and ensure patient safety. Samples must only be delivered to healthcare professionals under strict conditions of control and supervision.

Author:

Laura Fernández

Regulatory Affairs Specialist