Licensing Guidelines and Regulations

Enfoque por país/Portugal | Posted 24/02/2012 post-comment0 Post your comment

First posted: 24 February 2012 

The Portuguese healthcare system is organised as a national health service (Service National de Sáude, SNS), financed through general taxation, which provides health coverage to 75% of the population. The rest of the Portuguese are covered by one of the subsystems, funded mainly by contributions of employers and employees [1].

In Portugal, the different health and economics authorities are called upon to grant marketing approvals results in bureaucratic inefficiency and unreasonable delays of up to 400 days [2]. One factor contributing to these long delays is the high number of patent litigations between generics and originator companies in Portugal. In 2007 there were 50 court cases initiated by originator companies against marketing authorisations concerning the products of generics companies pending against the agency in charge of marketing authorisation [3].

The average time for a generic drug to obtain marketing authorisation in Portugal is more than 11 months, which is above the EU average of around seven months [4]. The average time interval between marketing authorisation and patient access to medicines is also one of the longer periods among the EU countries with 51% of medicines being available within 276 days after receiving marketing approval [5].

The National Institute of Pharmaceuticals and Medicines (Autoridade Nacional do Medicamento e Produtos de Saúde, INFARMED) established in 1993, is a government agency accountable to the Health Ministry and is the entity responsible for marketing authorisation of national human medicinal products [1, 6].

The medicine for human use is subject to standards of quality, safety and efficacy, grounded in the joint action of those responsible for marketing, the national competent authorities and the community [6].

Under legislation adopted on 30 August 2006 (Decree-Law no. 176/2006) there is a period of 8+2+1 years of data protection for originator medicines. Therefore, an application for a generic drug may be submitted in Portugal only eight years after the original marketing authorisation for the originator medicine. INFARMED can then authorise the generic medicine when the 10-year data protection period ends. There is an additional year of data protection for additional innovative indications [7].

Since Portugal is a member of the EU, approval of new drugs is governed by the rules and procedures that constitute the system of European regulation in this area [8].

The system comprises four European procedures for granting authorisation to market of a medicinal product in more than one Member State. They are:

Centralised Procedure
The authorisation to enter the market (Autorização de Introdução no Mercado, AIM) is valid in all Member States of the EU. The marketing authorisation application is managed by EMA via the Committee for Medicinal Products for Human Use (CHMP) appointed by each Member State. As part of the process, an expert draftsman and a co-rapporteur are selected who make independent assessments. The evaluation report is approved by the CHMP, and on this basis the European Commission takes a decision. This decision is published on the website of the European Commission (http://ec.europa.eu/health/documents/community-register/html/index_en.htm) [8].

Mutual Recognition Procedure
This procedure is based on national decisions which already exist. The first step in this procedure is to obtain marketing authorisation in a Member State of the EU (Reference Member State). That Member State shall give the first assessment and approves the drug nationally. This permit is the basis of the application to be submitted in other Member States [8].

Decentralised Procedure
This procedure can only be used when the product in question has no authorisation in any Member State. Although the request can be submitted in several Member States simultaneously, one will be the Reference Member State and prepare an assessment report. All other Member States involved will comment on that report, which will be updated when relevant [8].

National Procedure
Where it is intended that the drug is only approved for marketing in a Member State the procedure followed will be the national one [8].

References

1.  Österreichisches Bundesinstitut für Gesundheitswesen (ÖBIG). Surveying, Assessing and Analysing the Pharmaceutical Sector in the 25 EU Member States. July 2006.

2.  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.

3.  European Commission. Competition DG. Pharmaceutical Sector Inquiry Preliminary Report (DG Competition Staff Working Paper). 28 November 2008. 

4.  Glowicka E, Lorincz S, Pesaresi E, Sauri Romero L, Verouden V. Generic entry in prescription medicines in the EU: Main characteristics, determinants and effects. 8 July 2009. Available from: www.ec.europa.eu/dgs/competition/economist/prescription_medicines.pdf

5.  European Federation of Pharmaceutical Industries and Associations (EFPIA). The Pharmaceutical Industry in Figures. 2010.

6.  Autoridade Nacional do Medicamento e Produtos de Saúde (INFARMED). Medicamentos de Uso Humano [monograph on the Internet] Lisbon, Portugal, INFARMED [cited 2012 Feb 24]. Available from: www.infarmed.pt/portal/page/portal/INFARMED/MEDICAMENTOS_USO_HUMANO

7.  Pharmaceutical Pricing and Reimbursement Information (PPRI). Portugal. October 2008.

8.  Autoridade Nacional do Medicamento e Produtos de Saúde (INFARMED). Procedimentos de AIM [AIM Procedures - Portuguese] [monograph on the Internet]. Lisbon, Portugal, INFARMED [cited 2012 Feb 24]. Available from: www.infarmed.pt/portal/page/portal/INFARMED/MEDICAMENTOS_USO_HUMANO/AUTORIZACAO_DE_INTRODUCAO_NO_MERCADO/PROCEDIMENTOS_DE_AIM

Useful information sources

EMA, Committee for Proprietary Medicinal Products (CPMP). Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1) [monograph on the Internet]. London, UK: EMA; 24 July 2008 [cited 2012 Feb 24]. Available from: www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003011.pdf

EMA, Committee for Medicinal Products for Human Use (CHMP). EMA Procedural Advice for Users of the Centralised Procedure for Generic/Hybrid Applications (EMEA/CHMP/ 225411/2006) [monograph on the Internet]. London, UK: EMA; 2 July 2008 [cited 2012 Feb 24]. Available from: www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004018.pdf

EMA, Committee for Proprietary Medicinal Products (CPMP). Note for guidance on modified release oral and trans-dermal dosage forms: section II (pharmacokinetic and clinical evaluation) (CPMP/EWP/280/96) [monograph on the Internet]. London, UK: EMA; 1999 [cited 2012 Feb 24]. Available from: www.ema.europa.eu/pdfs/human/ewp/028096en.pdf

EMA, Committee for Proprietary Medicinal Products (CPMP). Note for guidance on the clinical requirements for locally applied, locally acting products containing known constituents (CPMP/EWP/239/95) [monograph on the Internet]. London, UK: EMA; 1995 [cited 2012 Feb 24]. Available from: www.ema.europa.eu/pdfs/human/ewp/023995en.pdf

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