España: Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs: Spain (III)

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 España: Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs: Spain (II)

Opioid Drugs

 For the purposes of this topic shall mean any industrially produced medicinal product which contains opioids.

25. Are Opioid Drugs authorized in your country?

Opioid Drugs may be authorized in Spain on the basis of scientific criteria on its quality, safety and efficacy. The foregoing is provided that applicable regulations on narcotics, such as Law 17/1967 on narcotics, and Royal Decree 2829/1977 on narcotics and its production, distribution, prescription and dispensation, are observed.

26. What are the regulatory authorities with jurisdiction over Opioid Drugs?

The main Spanish authorities with jurisdiction over Opioid Drugs are the Spanish Ministry of Health and the AEMPS.

27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?

No. The general regulatory framework applicable for the authorization, pricing and reimbursement of medicinal products apply to Opioid Drugs.

There are, however, specific regulations that may be applicable to other activities related to Opioid Drugs such as manufacturing, distributing, prescribing, dispensing etc. (see, among others, Law 17/1967, Royal Decree 2829/1977 and Royal Decree 1675/2012 on prescribing and dispensing narcotics for both human and veterinary use).

28. Which are the Opioid drugs that have received market approval to date?

There are many medicinal products containing opioids that have received market approval to date in Spain.

An updated and complete list of all medicinal products authorized in Spain classified by active ingredient (as well as by trademark, registration number, etc) can be found in CIMA, and online data base held by the AEMPS and available in the official website of the AEMPS. All medicinal products containing opioids that have received market approval in Spain are included in such list.

29. Who can prescribe Opioid Drugs?

Doctors, odontologists and veterinaries, each of them in the field of its competence, can prescribe Opioid Drugs.

30. Is there a list of doctors authorized to prescribe Opioid Drugs?

There is not a list of doctors authorized to prescribe Opioid Drugs. Doctors, provided that they comply with the applicable requirements and procedures (which include the need to use the appropriate prescription forms), can prescribe Opioid Drugs without need to be previously registered in any official list. It is to be noted that doctors holding prescription forms for narcotic drugs may be controlled (and therefore somehow listed), but these are lists relating to the prescription forms (holders of such forms are listed) and not related to the doctors themselves.

31. What approvals or notifications are required to prescribe Opioid Drugs?

Provided that applicable regulations are complied with (including the use of the appropriate prescription forms), doctors themselves do not have to ask for any specific approval or make any specific notification each time they prescribe Opioid Drugs.

Treatments with Opioid Drugs for patients addicted to Opioid Drugs have their specific regulations (such as Royal Decree 75/1990 on treatments with opiates for people addicted to opioids, and the circular of the AEMPS 6/2003 regarding the conditions to distribute narcotics for the treatment of people addicted to opioids.

32. Which organizations are authorized to sell/distribute Opioid Drugs available?

Opioid Drugs can be dispensed to the public by authorized pharmacy offices/services.

Opioid Drugs can be distributed (that is, sold to either other authorized distribution entities or pharmacy offices/services) by any of the following entities provided that they comply with all applicable regulations on medicinal products and narcotics (such as Law 17/1967, Royal Decree 2829/1977 -and its complementary regulations- and Royal Decree 1675/2012):

Pharmaceutical laboratories; Distribution entities duly authorized to distribute medicines for human use (see Royal Decree 782/2013); and/or Distribution entities duly authorized to distribute veterinary medicines (see Royal Decree 109/1995).

33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?

Retailers. The AEMPS, with the cooperation of the regional authorities, publishes lists including all pharmacy offices opened to the public in Spain. Such pharmacy offices can dispense Opioid Drugs if they comply with applicable regulations (please refer to Question 32).

Distributors. The AEMPS publishes lists including all entities authorized to distribute veterinary medicines and medicines for human use in Spain. All entities authorized to distribute Opioid Drugs must be included in such lists.

34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?

We are not aware of any proposal to significantly reform the regulation of Opioid Drugs in Spain.

35. When are they likely to come into force

N/A

Cannabinoid drugs, medicinal cannabis and opioid drugs in Spain – a legal guide. 
Prepared in association with Faus & Moliner Abogados, a leading law firm in Spain, this is an extract from 
The Pharma Legal Handbook: Spain