Variation application for homeopathic medicinal products

A change of a registered homeopathic medicinal product may be performed only after permission from the Swedish Medical Products Agency (MPA).

Examples of changes are; change of manufacturer or supplier, change of composition of excipients, change of manufacturing method, change of quality standards, change of design or size of the packaging. See provisions LVFS 1997:9, changed and reprinted through LVFS 2003:2 (can be found on the right hand side), Part 6. Modifications and withdrawals. Examples of changes are listed in Guidelines relating to Part 6. (LVFS 2003:2). The variation application including relevant documentation should be sent to the MPA before a decision can be made.

To simplify the variation application procedure, the application form “Variation application for homeopathic medicinal products” can be used (can be found on the right hand side).

Variation applications for homeopathic medicinal products are not regulated by the variation regulation (EC) No 1234/2008 and LVFS 2006:11. However, these regulations may act as support when applying for a variation for homeopathic medicinal products. For examples of changes, conditions and documentation, see Commission Procedural Guideline and Application for variation to a marketing authorisation where various changes are listed. 

Application for variation to a marketing authorisation is used by the Swedish Medical Products Agency as a basis to assess whether the applicant has categorised the variation of the homeopathic medicine properly. Based on this document, one may determine variations as type IA/IB or type II, and into one of the three categories: administrative, quality or safety.

The time table for the variation procedures of type 1A/1B for homeopathic medicinal products is normally 60 days. For major variations of type II, the time table for the procedure is 120 days.

Regarding grouping of variations, the MPA supports the CMDh recommendations for acceptable groupings for purely nationally authorised products also (see ”Examples for acceptable and not acceptable groupings for MRP/DCP products” on CMDh:s webpage.

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