Purely National Variation Procedures
In which cases should I submit a purely national variation procedure?
As of 4 August 2013, the rules laid down in Chapter IIa of Commission Regulation (EC) No 1234/2008 of 24 November 2008 ("Variation Regulation") as amended by Commission Regulation (EU) No 712/2012 of 3 August 2012 continue to be applicable for the submission and assessment of variations to the terms of purely national marketing authorisations.
The following medicinal products are exempted from the scope of this regulation:
- Authorised homeopathic medicinal products for human use authorised or regarded as authorised prior to 1 January 1998
- Registrations of homeopathic medicinal products pursuant to Section 38 AMG
- Registrations of traditional herbal medicinal products pursuant to Section 39 a-d AMG
- Parallel imports
- Standard marketing authorisations pursuant to Section 36 AMG
For variations to the terms of marketing authorisation of medicinal products outside the scope of Commission Regulation (EC) No 1234/2008, Section 29 of the German Medicinal Products Act (AMG) remains applicable.
The following changes are regarded as outside the scope of Commission Regulation (EC) No 1234/2008 and therefore are to be submitted as purely national variations pursuant to Section 29 (1) AMG:
- Transfer of marketing authorisation to a new holder
- Change regarding co-marketing
- Change regarding the local representative and/or distributor
- Change in legal status resulting from adoption or change in the legal regulation on the legal status of medicinal products as long as no further amendments of the product information are necessary
- Editorial changes to the national package leaflet, immediate and secondary packaging only
Further information on purely national variation procedures in accordance with Section 29 AMG is available on our homepage under Variations national
Which medicines are affected by the AnalgetikaWarnHV?
The regulation applies to:
- Purely national marketing authorisations
- Marketing authorisations following a mutual recognition procedure or a decentralised procedure (MRP / DCP)
- Parallel import marketing authorisations
- German standard marketing authorisations
How is the BfArM to be notified of adaptions to the Analgetika-Warnhinweis-Verordnung (AnalgetikaWarnHV)?
The adaptation has to be submitted as national change notification pursuant to Section 29 (1) or for a German standard marketing authorisation pursuant to Section 67 (5) of the German Medicinal Products Act (AMG). The correct implementation in accordance with Section 2 (3) of the AnalgetikaWarnHV should either be confirmed or alternatively a labelling draft of the outer packaging or the immediate packaging should be enclosed.
It is recommended to submit the change notification via PharmNet.Bund.
Which transitional periods should be considered in connection with the AnalgetikaWarnHV?
Medicinal products authorised before 1 July 2018, and affected by the AnalgetikaWarnHV may be placed on the market without the required warning 2 years after the regulation became effective, which means until 30 June 2020.
All medicinal products authorised after 1 July 2018, and affected by the AnalgetikaWarnHV may only be placed on the market if the labelling contains the requested warning.