Licensing Guidelines and Regulations

Enfoque por país/Spain | Posted 14/10/2011 post-comment0 Post your comment

Under dictatorship there was a means-tested and centralised healthcare system, rooted in a social security scheme. The Spanish Constitution established the rights of all Spaniards to health care and set out a new regionally-based organisational framework. The National Health Institute was created in 1978 and the Ministry of Health in 1981 [1].

In 1986, the General Health Law established a National Health Service (NHS) in Spain. It is a universal healthcare management decentralised system, with universal coverage and finance from general taxation [2].

The 1990 Medicines Act was modified in 1996 and in 1997 in order to pave the way for the introduction of generic medicines within the Spanish healthcare market. In July 1997, the first generics were authorised for commercial distribution [2].

The Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) is the national authority responsible for regulation of drugs in Spain. AEMPS was established in 1999 as the health authority of reference for citizens and health professionals in the field of quality assurance, safety, efficiency, information and accessibility of drugs and medical devices [3, 4].

AEMPS combined activities and responsibilities which until then were carried out by the Dirección General de Farmacia y Productos Sanitarios (Spanish Pharmacy and Medical Devices Administration) and the Centro Nacional de Farmacobiologia (Spanish Centre for Pharmacobiology) [4].

In Spain, generic drugs are regulated according to Law 29/2006 of 26 July 2006, which guarantees the rational use of medicines and medical devices and Royal Decree 1345/2007 of 11 October 2007, which regulates the authorisation procedure, registration and conditions of supply of medicinal products for human use manufactured industrially, as well as the rational use of medicines [4, 5].

The average time for a generic drug to obtain marketing authorisation in Spain is more than 14 months, which is second only to Greece in the EU for being one of the longest delays and which is well above the EU average of around seven months [6, 7].

All medicines including generics must obtain a marketing authorisation, which AEMPS will grant after assessing their quality, safety and efficacy. Authorised medicines are then published online on the AEMPS Medicine Information Centre (Centro de Información Online de Medicamentos, CIMA), which is regularly updated. No medicine can be marketed or sold in Spain without prior authorisation from the AEMPS or the European Commission [4].

In Spain, generic medicines, provided they meet the requirements set out in Royal Decree 1345/2007, carry the EFG abbreviation, which stands for Equivalentes Farmacéuticos Genéricos (Equivalent Generic Medicine). This abbreviation differentiates generic medicines from the branded or originator medicine [8].

According to the Royal Decree 1345/2007 a generic medicine is a medicine that has the same qualitative and quantitative composition with respect to active ingredients and the same pharmaceutical form, and whose bioequivalence with the reference medicine has been demonstrated by appropriate bioavailability studies [9].

Generic medicines may be marketed in Spain 10 years from the date of the initial authorisation of the reference medicine either in Spain or in another EU country. This period of 10 years may be extended up to a maximum of 11 years if, during the first eight years of the 10-year period, the holder of the authorisation of commercialisation of the reference medicine obtains a new authorisation for one or more therapeutic indications [9].

There are four different procedures for granting marketing authorisation of a medicinal product in Spain:

National procedure

The applicant presents a dossier for authorisation to the AEMPS with all the information required for the marketing authorisation in Spain [4].

Decentralised procedure

The applicant presents an application for authorisation simultaneously in several EU member countries. Different agencies will assess the medicine in a coordinated fashion, with one agency assuming the coordination or key role. At the end of the process, each agency will issue an identical authorisation, which will be valid for its area of jurisdiction [4].

Mutual-recognition procedure

This occurs when a medicine has already received a marketing authorisation within the EU. The holder of this authorisation may present an application for recognition of the authorisation in other EU Member States, notifying both the Member State which has issued the authorisation - the key Member State, and EMA. The key Member State will send the medicine assessment report to the states involved, which in turn will recognise the initial authorisation for marketing and sale [4].

Centralised procedure

The applicant applies for authorisation in all the EU Member States at the same time. In this case, EMA will take responsibility for the administrative process, and the scientific assessments will be carried out by two Member States (rapporteur and co-rapporteur) which will send their reports to the other Member States. A scientific committee, a subsidiary of EMA, takes responsibility for preparing reports on any questions pertaining to the medicine assessment. Once a positive technical report has been issued, the European Commission will grant the applicant authorisation for marketing and sale of the medicine, which will be valid throughout the EU [4].

Around 50% of the 1,000 new marketing authorisations issued by AEMPS each year are via the national procedure [4].

References

1. European Observatory on Healthcare Systems. Healthcare Systems in Transition. HIT Summary: Spain, 2002.

2. Vogler S, Espin J, Habl C. Pharmaceutical Pricing and Reimbursement Information (PPRI) – New PPRI analysis including Spain. Pharmaceuticals Policy and Law. 2009;11(3):213-34.

3. Agencia Española de Medicamentos y Productos Sanitarios (AEMPS). Misión y Visión de la Agencia Española de Medicamentos y Productos Sanitarios Marzo de 2009 [Spanish] [MISSION AND VISION OF THE SPANISH AGENCY FOR MEDICINES AND HEALTH PRODUCTS March 2009] [monograph on the Internet] Spain, AEMPS [cited 2011 October 14]. Available from: www.aemps.es/en/actividad/nosotros/mision/home.htm

4. Agencia Española de Medicamentos y Productos Sanitarios (AEMPS). How are Medicines and Medical Devices regulated in Spain? First edition: 2010.

5. Ministerio de Sanidad Politica Social e Igualdad [Ministry of Health Social Policy and Equality] . Preguntas frecuentes sobre medicamentos genéricos [Spanish] [FAQ Generic Drugs] [page on the Internet]. Madrid, Spain [cited 2011 October 14]. Available from: www.medicamentosgenericosefg.es/consumo-genericos-espana.html

6. AESEG. La industria y el mercado del genérico en España [Spanish] [The industry and the generic market in Spain]. 16 December 2009.

7. Bongers F, Carradinha H. European Generic medicines Association (EGA) Health Economics Committee. How to Increase Patient Access to Generic Medicines in European Healthcare Systems. June 2009.

8. AESEG. Generic Medicines in Spain [Spanish] [page on the Internet]. Madrid, Spain, AESEG [cited 2011 October 14]. Available from: www.aeseg.es/english/aeseg_genericos_en_espana.asp

9. Real Decreto1345/2007, de 11 de Octubre, por el que se Regula el Procedimiento de Autorización, Registro y Condiciones de Dispendación de los Medicamentos de Uso Humano Fabricados Industrialmente (BOE núm. 267, de 7 noviembre [RCL 2007, 2011]) [Spanish] [Royal Decree 1345/2007, of 11 October, Regulating the Procedure of Authorization, Registry and Conditions of Dispensing of Medicines for Human Use Made Industrially]. 11 October 2007.

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