The European Medicines Agency (EMA), which operates in Amsterdam, is responsible for the scientific evaluation of applications for marketing authorisations for medicinal products in Europe via the centralised procedure. The use of the centralised procedure is compulsory for medicinal products obtained by means of biotechnology and other high-technology methods intended for the treatment of HIV, cancer, diabetes or neurodegenerative diseases, and for orphan medicinal products intended for the treatment of rare diseases.
The medicinal product marketing authorisation is issued by the European Commission and is applicable in all EU Member States. Notification of the marketing authorisation is published in the Official Journal of the European Union.
Prior to their placement on the market of the Republic of Slovenia, medicinal products that have obtained EU marketing authorisation through the centralised procedure should also obtain:
- National indentification code,
- Legal status for supply in the Republic of Slovenia (“blue-box” information),
- Pictogram(s) of precaution measures if applicable with respect to the nature of the medicinal product (“blue-box” information).
For each EU Member State the requirements are detailed in the Guidelines on the Packaging Information of Medicinal Products for Human Use Authorised by the Community (informations regarding Slovenia are currently being revisied)
Obtaining the data
Application for obtaining the national indentification code, Legal status for supply and pictograms of precaution measures shoud be submitted in paper format (obligatory) and electronic format (optional). It should include:
- Completed and signed form »Application for obtaining the data required to place the centrally authorised medicinal products on the market of the Republic of Slovenia«
- letter of authorisation from the marketing authorisation holder when the application is submitted by its representative
- a copy of the EC Decision on marketing authorisation and the SmPC, if not yet available on the web portal of the European Commission:(http://ec.europa.eu/health/documents/community-register/html/index_en.htm)
- for the new packagings/strengths/pharmaceutical forms subject to variations other than Article 23(1a)(a) of the Commission Regulation (EU) No 1234/2008, amended by the Commission Regulation (EU) No 712/2012, the positive CHMP opinion (if the EC Decision for the new presentations has not been issued yet)
- completed form »Application for obtaining the data required to place the centrally authorised medicinal products on the market of the Republic of Slovenia« in Word format
- SmPC in Slovenian, if not yet available on the web portal of the European Commission
NOTE: Since 3.3.2018, the application fee in accordance with the List of rates of the Public Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (Official Gazette of the Republic of Slovenia, No. 9/18) is paid for these applications, upon the receipt of JAZMP Notice. The administrative fee is no longer applicable.
Changing the data
In case of the proposed change of legal status for supply and/or pictograms of precaution measures the application should include the cover letter including the grounds of the proposed change.
National indentification code is not subject to changes throughout the lifecycle of the medicinal product.
EUROPEAN MEDICINES AGENCY (EMA)
EMA runs six scientific committees, composed of representatives of the EU Member States and EEA-EFTA countries, which also include representatives of patients and physicians. These perform the main scientific work of EMA; besides the committees referred to below, a number of working groups function as scientific support to the committees.
- Committee for Medicinal Products for Human Use (CHMP) is an expert body at the EMA, responsible for the assessment of medicinal products for human use, consisting of representatives of EU member states and individually appointed experts.
- Pharmacovigilance Risk Assessment Committee (PRAC) is an expert body at the EMA, responsible for the assessment and monitoring of safety of medicinal products for human use, consisting of representatives of EU member states, individually appointed experts, representatives of healthcare professionals and patient organizations.
- Paediatric Committee (PDCO) is an expert body at the EMA, consisting of experts competent in the assessment of all aspects of medicinal products used in paediatric population, including the development of such medicinal products.
- Committee for Advanced Therapies (CAT) is an expert body at the EMA, consisting of experts in various fields whose task is scientific assessment of medical products for advanced treatments, terms of their use, and following the scientific development in the field.
- Committee on Orphan Medicinal Products (COMP) is an expert body at the EMA, responsible for reviewing the applications of pharmaceutical companies that are planning to develop medicinal products to be used in the treatment of rare diseases (the so-called “orphan medicinal products”).
- Committee on Herbal Medicinal Products (HMPC) is an expert body at the EMA, responsible for establishing EU monographs covering the therapeutic uses and safe conditions of well-established and/or traditional use for herbal substances and preparations, drafting an EU list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products, and also for performing other tasks in accordance with the Directive 2001/83/ES.
EMA integrates the scientific resources of over 40 competent national authorities in 30 EU Member States and EEA-EFTA into a network of more than 4,500 European experts. It contributes to the international activities of the European Union in cooperation with the European Pharmacopoeia, World Health Organization and International Conference on Harmonisation (ICH).
For more information about EMA visit: http://www.ema.europa.eu/