Regulatory Affairs

We accompany you in selected questions about regulatory affairs and also questions regarding Market Access in Germany.

 

Implementation of change notifications in accordance with variation regulation (2013/C 223/01) of the EU

 

ClassificationExamples: Content of amendment
Type IARenaming of the authorisation holder or producer
Elimination of manufacturing place
Narrowing of specifications
Type IBNew manufacturing place
Changes regarding dosage form, primary packaging,
secondary packaging or changes regarding the batch volumes
Type IIChanges in process of producing, enlarging of speifications
No classificationTransmission of authorisation
Joint contractor or national sales differentation

Application of pharmaceutical registration numbers

 

-> Primary and changing notifications

 

 

Pricing

 

-Strategic pricing regarding finished medical products.

-Utilisation of required, and avoidance of undesirable price swing effects alluded to in the ยง130 a SGB V

-Continuous monitoring of market price changes and implementation of a reporting system

-Constant monitoring of relationship of discounted contracts and public tenders

 

Preparing your Market Access

 

-Leading of pre-negotiation with pharmaceutical wholesalers up to the conclusion of contract with the pharmaceutical bidders

-Taking into account the possible impact of discounted contracts on your business in and outside of public tenders.

-Preparing eligible submissions in due time and due form

 

We also conduct research into questions about Market Approvals.