Applications for new authorisations, variations and renewals

Four distinct procedures exist for applying for marketing authorisations for medicinal products in Sweden.

The centralised procedure

The centralised procedure is mandatory for all medicinal products developed through certain types of biotechnology processes, certain products used in advanced drug therapies, products designated as orphan medicinal products, and veterinary products designed for performance-enhancing (growth promoting) purposes or to increase yields. Applications involving new active substances for indications such as AIDS, cancer, diabetes, neurodegenerative disorders, autoimmune diseases/other immune dysfunctions and viral diseases must also be submitted through the centralised procedure. The procedure may also be used in cases where the applicant for example can show that the medicinal product constitutes an important therapeutic, scientific or technological innovation.

The assessment is made by the two national competent authorities appointed as Rapporteur and Co-Rapporteur respectively by the CHMP/CVMP (Committee for Human Medicinal Products/Committee for Veterinary Medicinal Products). The assessment shall be completed within 210 days.  The final opinion of the CHMP/CVMP is forwarded by the EMA to the EU Commission, where a decision will be made after consultation with the Member States in the Standing Committees. Authorisation of medicinal products via the centralised procedure will entitle the companies in question to sell these products throughout the EEA.

The mutual recognition procedure and the decentralised procedure


An application is assessed by the competent authority in the Reference Member State (RMS) chosen by the company.

By using the mutual recognition procedure, a company may request that an existing national authorisation shall be recognised in other EEA countries. If a company has obtained a national authorisation for a medicinal product, this procedure is mandatory. The authority which has issued the national authorisation is chosen as an RMS. Its assessment is used as a basis for authorisations in any additional countries (Concerned Member States – CMS) in which the company is seeking to obtain marketing authorisations for its product(s). The mutual recognition procedure may also be used if the company thereafter wishes to extend the authorisation to further member states in the EEA at a later date (repeat use). In both cases, the RMS has 90 days to update the assessment report issued during the earlier national or previous mutual recognition procedure before the assessment report shall be sent to the CMS. The total processing time between submission of the documentation to the CMS and a final decision may not exceed 90 days.

The decentralised procedure is applicable in cases where a company wishes to obtain marketing authorisations in a number of EEA countries for a medicinal product that has no previous authorisation. The company files an application with an RMS, which will then make the assessment. However, unlike the mutual recognition procedure, the product will be authorised by the RMS and the CMS concurrently. The assessment shall be completed within 210 days.

If a CMS cannot recognise/approve a medicinal product based on the documentation sent to it by the RMS, the matter is referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – human/veterinary (CMDh/CMDv). The Co-ordination group shall try to reach agreement by consensus. This applies to both procedures. If such an agreement cannot be reached, the matter is referred to the CHMP/CVMP and the EU Commission for arbitration. If the CMS’s objection is supported following a mutual recognition procedure, the application is rejected and the authorisations for the product shall be revoked in that/those Member State/s where it has previously been given. If the CMS’s objection is supported following a decentralised procedure, the application is rejected. If the RMS considers that an application cannot be approved in a decentralised procedure, the matter is not referred to the CMD. The application is rejected unless it has already been withdrawn by the company in member states.

The national procedure

Since 1 January 1998, authorisation through the national procedure is obtainable only for medicinal products intended for marketing in a single country. The assessment shall be completed within 210 days.

Variations and renewals


Marketing authorisations for medicinal products must be renewed within five years from the date of authorisation. A company seeking a renewed authorisation must submit a renewal application. If a renewed authorisation is approved, the authorisation is valid without time limit unless there are safety issues. If such issues are at hand the renewal will be granted for another five year period.

Variations in authorised medicinal products must be specified in variation applications submitted by the company to the authority.

 
 
 

Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | phone: +46 18 174600, fax: +46 18 548566 | Contact information