Regulatory advice

Regulatory advice

• Questions of a regulatory nature regarding already approved medicinal products.
• Questions on selecting a procedure for a new marketing authorization application.
• General questions regarding product information such as labelling changes etc.
• General naming issues
• Procedural issues for herbal medicines and topical medicines (Vissa utvärtes läkemedel, VUM)

The advice does not include:

• Questions relating to interpretation of guidelines regarding efficacy, safety or quality. These questions are classified as scientific advice.
• Questions regarding GxP-related issues such as wholesale and manufacturing permits.
• Questions related to Medical Devices, Cosmetics and Hygiene products.
• Licensing of narcotics and narcotic precursors.
• Translation assistance.
• Issuing of SME certificates.

The Regulatory advice is primarily intended to meet the need for regulatory support from small and medium-sized national pharmaceutical companies, but we accept questions from all companies.

Incoming questions

Questions are sent to registrator@lakemedelsverket.se

Questions will primarily be answered via email or by telephone and our goal is that questions will be answered within two weeks. However, depending on the nature and extent of the questions, it may take longer before answers can be given.

For more complicated issues, the Swedish Medical Products Agency can also provide advice at a meeting.

Regulatory advice is free of charge and can be done separately or in conjunction with scientific advice.

Application

Comprehensive answers to regulatory questions related to the Mutual recognition procedure and Decentralised procedure can be found at the Co-Ordination Group for Mutual Recognition and Decentralized Procedures.