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
|Classification||Examples: Content of amendment|
|Type IA||Renaming of the authorisation holder or producer
Elimination of manufacturing place
Narrowing of specifications
|Type IB||New manufacturing place
Changes regarding dosage form, primary packaging,
secondary packaging or changes regarding the batch volumes
|Type II||Changes in process of producing, enlarging of speifications|
|No classification||Transmission of authorisation
Joint contractor or national sales differentation
Application of pharmaceutical registration numbers
-> Primary and changing notifications
-Strategic pricing regarding finished medical products.
-Utilisation of required, and avoidance of undesirable price swing effects alluded to in the §130 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.