§ 73.3 Premarketing within the framework of HWG

The import of finished medicines that have not been approved in the Federal Republic of Germany (§ 73.3 AMG and § 3 BTMG) and their distribution to public and hospital pharmacies as well as the pharmaceutical wholesale trade.

Initial basis

The pharmaceutical research and production industry is interested in ensuring that medicines

• That are registered for approval by the Federal German Agency for Medicines, or
• That, in future, are to be registered with the Federal German Agency for Medicines for approval, or
• That, for marketing reasons, are to be - or have already been - withdrawn from the German market, or
• That are not envisaged for approval in Germany, or
• That are imported under due observation of all legal stipulations and will continue to be made available to the health service on the German market.

Aim

A pharmaceutical manufacturer intends to conduct concentrated market preparations and research within the given legal possibilities before a pharmaceutical product is approved so that after approval by the Federal German Agency for Medicines the findings can be used by the marketing and sales departments to launch the given product.

Restrictions

The Medicine Law does not allow a pharmaceutical manufacturer in Germany to import into Germany and distribute a finished medical product that is subject to the status stated in Point 1 - as in the sense of active sales and advertising.
Furthermore, the manufacturing pharmaceutical company is not allowed to store within the legal area of the German Federal Republic any finished medicines that are supplied to the market outside clinical studies.

Sale of – OTC Products / View field service

Our company additionally provides for the distribution of Pharma / OTC Products, including field service deployment for special tropical medicines.
 
Initial basis

To reduce costs and/or for reasons of company strategy, a given pharmaceutical manufacturer is not interested in distributing pharmacist controlled medicines to clients in the pharmacy and clinic areas. Next to the actual distribution, this area also covers the entire process of order acceptance and order processing, storage and invoicing, batch monitoring and cash management.

Refrigerated chain delivery is just as much a matter of course as correct delivery with products that are subject to the narcotics law and the entire field of documentation.

Trained specialist personnel, the most modern EDP hardware in order acceptance/client service, invoicing and logistics guarantee that our joint clients are properly supplied.

Our Logistics Centre has taken all the necessary measures to ensure that temperature sensitive products are properly handled. Many years of corresponding experience and close links with leading national and international carriers guarantee the fastest possible delivery.