Licensing Guidelines and Regulations

Enfoque por país/Denmark | Posted 07/12/2011 post-comment0 Post your comment

Denmark has a state-run healthcare system, which has retained the same basic structure since the early 1970s. The administration of hospitals and personnel is dealt with by the Ministry of the Interior, while primary care facilities, health insurance, and community care are the responsibility of the Ministry of Social Affairs [1, 2].

Health care is free to anyone who receives a Danish residence permit and a civil registry number [3]. Costs are borne by the public authorities, but high taxes contribute to these costs [1, 2].

The Danish Medicines Act (Lægemiddelloven, Consolidated Act No. 1180 of 12 December 2005) provides the legal framework for the control of medicines in Denmark [4].

The average time for a generic drug to obtain marketing authorisation in Denmark is less than three months, which is the shortest in the EU and well below the EU average of around seven months [5]. The average time interval between marketing authorisation and patient access to medicines is also one of the shorter periods among the EU countries with 89% of medicines being available within 138 days after receiving marketing approval [6].

The Danish Medicines Agency (Lægemiddelstyrelsen, DKMA), an agency under the Ministry of Interior and Health, was established on 1 January 1997 and is the governmental body responsible for the licensing of medicines in Denmark [7].

DKMA is also responsible for market surveillance and vigilance, decides on reimbursement eligibility of pharmaceuticals and is involved in the pharmacoeconomics (consumption analysis, monitoring of prices, etc.) [8].

The agency aims to ensure that medicinal products used in Denmark are of satisfactory quality, are safe to use and that they have the desired effect.

A licence, also referred to as a marketing authorisation, from DKMA is required before any medicine can be used to treat people in Denmark.

Pharmaceutical companies can apply for a marketing authorisation for a medicinal product, whether an originator or generics product, in four different ways [9]:

Centralised procedure
New and high technology medicinal products are authorised in the entire EU simultaneously. EMA is responsible for this procedure. In turn, the individual Member States are responsible for the scientific evaluation of applications. The centralised procedure is compulsory for biotechnological medicinal products and orphan drugs.

Decentralised procedure
Companies can apply for authorisation in more than one EU/EEA (European Economic Area) country simultaneously and for which no EU/EEA country has granted a national authorisation. The Reference Member State (RMS) is responsible for the procedure and for the scientific evaluation of the application.

Mutual recognition authorisation procedure
The marketing authorisation for a medicinal product, which has already been authorised in accordance with the national procedure in one EU/EEA country (the RMS), forms the basis for authorisation in another EU/EEA country. The RMS is responsible for the procedure and the scientific evaluation of the application.

National authorisation procedure
The medicinal product is exclusively authorised in one Member State. At a later date, the authorisation may form the basis of an application via the mutual recognition procedure.

When companies apply for authorisation of generic medicinal products, the Danish authorities impose a number of general and specific requirements on the results of bioequivalence studies which the companies submit with their generics application. The requirements apply to both authorisation of generic medicinal products, and the subsequent labelling with regard to generics substitution on the Danish market. The general labelling requirements on substitution apply regardless of whether the generics are authorised based on bioequivalence or therapeutic equivalence [10].

DKMA categorises all marketed pharmaceuticals by their Anatomic Therapeutic Chemical Code and groups those with the same active ingredient. Pharmaceuticals in the same group are considered to be interchangeable, meaning that they may substitute each other, i.e. generics substitution may occur [8].

Substitution can be made between synonymous medicinal products of the same strength and, usually, of the same pharmaceutical form (with some exceptions), and where a direct therapeutic equivalence or bioequivalence has been documented. All medicinal product groups and substances are included in the substitution system [10].

The list of substitutable pharmaceuticals is updated on a regular basis and available on the internet [8].

References

1. ESS-Europe.de. Europavergeleich der Sozialsysteme [monograph on the Internet]. Germany, ESS c2005 [cited 2011 December 06]. Available from: www.ess-europe.de/en/denmark.htm

2. Encyclopedia of the Nations. Denmark – Health [monograph on the Internet]. c2011 Advameg Inc. [cited 2011 December 06]. Available from: www.nationsencyclopedia.com/Europe/Denmark-HEALTH.html

3. New to Denmark.dk. Healthcare in Denmark [monograph on the Internet]. The Ministry of Refugee, Immigration and Integration Affairs [cited 2011 December 06]. Available from: www.nyidanmark.dk/en-us/Integration/informationguide/healthcare/healthcare_in_denmark.htm

4. Danish Medicines Agency (Lægemiddelstyrelsen, DKMA). 1180 of 12.12 2005th Medicines Act (Medicines Act) [monograph on the Internet]. Copenhagen, Denmark, DKMA [cited 2011 December 06]. Available from: http://lms-lw.lovportaler.dk/showdoc.aspx?docId=lov20051180-full

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

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

7. Danish Medicines Agency (Lægemiddelstyrelsen, DKMA). The Danish Medicines Agency [monograph on the Internet]. Copenhagen, Denmark, DKMA [cited 2011 December 06]. Available from: www.dkma.dk/1024/visUKLSArtikelBred.asp?artikelID=744

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

9. Danish Medicines Agency (Lægemiddelstyrelse, DKMA). Authorisation of medicinal products [monograph on the Internet]. Copenhagen, Denmark, DKMA [cited 2011 December 06]. Available from: www.dkma.dk/1024/visUKLSArtikel.asp?artikelID=1585

10. Danish Medicines Agency (Lægemiddelstyrelsen, DKMA). Bioequivalence and labelling of medicinal products with regard to generic substitution [monograph on the Internet]. Copenhagen, Denmark, DKMA [cited 2011 December 06]. Available from: www.dkma.dk/1024/visUKLSArtikel.asp?artikelID=6437

Useful information sources

EMA, Committee for Proprietary Medicinal Products (CPMP), Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1) 24 July 2008 [monograph on the Internet] London, UK, EMA [cited 2011 December 06]. 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) 2 July 2008 [monograph on the Internet] London, UK, EMA [cited 2011 December 06]. 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) 1999 [monograph on the Internet] London, UK, EMA [cited 2011 December 06]. 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) 1995 [monograph on the Internet] London, UK, EMA [cited 2011 December 06]. Available from: www.ema.europa.eu/pdfs/human/ewp/023995en.pdf

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