Apply for a license for the wholesale of medicinal products

If you wish to operate a wholesale business with medicinal products, you require a permit from the competent authority. You can find out more here.

If you wish to operate a wholesale business with medicinal products for human use, you generally require a license from the competent authority before starting your business.

Human medicinal products are medicinal products within the meaning of the Medicinal Products Act that are intended for use in humans.

Wholesale trade in medicinal products is defined as any professional or commercial trade that

• procures,
• stores,
• dispenses or
• exports them.

The supply of medicinal products to consumers other than doctors, dentists, veterinarians or hospitals is not considered wholesale.

You can only be granted a wholesale license if you meet certain personal and factual requirements. In particular, you must appoint a responsible person who has the necessary expertise to carry out the activity.

The permit is only valid for the respective business premises and for the activities and medicinal products for which the permit is issued. If you wish to operate several business premises, you can obtain information from the competent authority as to whether a separate application is required for each business premises.

If you have applied for a wholesale authorization, your business premises are subject to monitoring by the competent authority.

Natural persons, legal entities, associations without legal capacity and civil law companies are eligible as applicants.

The competent authority is the Hessian State Office for Health and Care (HLfGP).

Please contact the Hessian State Office for Health and Care (HLfGP).

When applying for a wholesale authorization, you must:

• name the specific establishment and the activities and medicinal products for which the authorization is to be granted
• provide evidence that you have suitable and sufficient premises, facilities and equipment for
  • proper storage
  • proper distribution
  • where provided, proper decanting, packaging and labeling of medicinal products
• name a responsible person who has the necessary expertise
• enclose a declaration in which you undertake to comply with the regulations applicable to the proper operation of a wholesale business.

• You would like to operate a wholesale business with medicinal products.
• Your establishment or company is already registered in the SPOR database of the European Medicines Agency (EMA). SPOR stands for Substance, Product, Organization, Referentials.

• Designation of at least one Hessian operating site,
• suitable and sufficient premises, facilities and equipment,
• Appointment of a responsible person with the necessary expertise,
• reliability of both the applicant and the responsible person.

• You submit your application to the competent authority by e-mail.
• The permit will be issued if the competent authority determines that the legal requirements have been met.
• In the case of a new application, an appointment must be made for an inspection of the wholesale business before the start of operations.

You may only start work once you have received permission.

You do not require a license to wholesale medicinal products for

• the distribution of finished medicinal products released outside pharmacies which
  • are medicinal waters and their salts in their natural mixing ratio or their imitations and
  • may be dispensed in the itinerant trade
• Activities that are carried out as a pharmacy as part of normal pharmacy operations.

In order for the authorities to be able to fulfill their monitoring obligations, "companies and facilities that develop, manufacture, clinically test or subject to residue testing, test, store, package, place on the market or otherwise trade in medicinal products" must be notified.