Regulatory Advice from the Medical Products Agency

The Swedish Medical Products Agency offers regulatory advice, aimed at supporting companies in regulatory matters. Questions are handled and administered directly or answers are compiled from other units at the MPA.

Advice is offered about:

  • All issues of a regulatory nature regarding approved medical products. 
  • Questions about choice of procedure.
  • General questions involving product information, such as changes in labelling.
  • General questions about trade names.
  • Procedural questions about herbals and certain products for external use.

The advice does not cover:

  • Issues surrounding the interpretation of guidelines referring to effect, safety or quality. These  questions are classified as scientific advice.
  • Questions about rules for GxP-related matters, such as wholesalers license or  manufacturing license.
  • Questions related to the areas of medical devices, cosmetic and hygienic  products.
  • Licenses regarding use of alcohol for industrial and scientific purposes, alcoholic drugs, narcotics,  needles and syringes, and certain products that are injurious to health.
  • Translation assistance. 
  • Issuing of SME certificates.
     

The advice is chiefly intended to meet the needs of small and medium sized domestic pharmaceutical companies for regulatory support, but questions will be accepted from all companies.

Submitted questions will primarily be answered, if possible, by e-mail or telephone. For more complicated issues, the Medical Products Agency may also give advice at a meeting. The regulatory advice is free of charge and can take place separately or in connection with scientific advice.
 
An application for a meeting about regulatory advice can be made by filling in the form ”Application for Scientific and/or Regulatory Advice” and sending it to the registrar at the Medical Products Agency.

 
 

Related information

 

Related information

Responses to regulatory issues related to the mutual and decentralized procedure are available from Co-ordination Group for Mutual Recognition and Decentralized Procedures(Human).

 FAQ CHM(h)

 FAQ (CMDv)

 

Contact Information

Application form and inquiries in general should be addressed to the MPA registrar.

   
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information