Pharmaceuticals; application for a customs certificate
A customs certificate is required if, for example, companies want to import medicines from third countries into the scope of the Medicines Act.
For the customs clearance of medicinal products for free circulation in the case of Section 73, Paragraph 1, Sentence 1, No. 2 and Paragraph 1a, No. 2 in conjunction with Paragraph 1, Sentence 1, No. 2 of the German Medicines Act (AMG), the submission of a certificate from the authority responsible for the recipient is required, in which the medicinal products are designated and it is confirmed that the requirements of Paragraph 1 or Paragraph 1a are met.
The following are responsible for the certificate
- the Government of Upper Bavaria for the administrative districts of Upper Bavaria, Lower Bavaria and Swabia;
- the Government of Upper Franconia for the administrative districts of Upper, Middle and Lower Franconia and Upper Palatinate.
The prerequisite for this is the marketability (marketing authorization according to § 21 ff. AMG) of the medicinal products to be imported.
The application with the required documents should be sent to the relevant government.
The customs certificate can only be issued after all required documents have been submitted and open questions have been clarified.
Proof of approval
GMP certificates of the manufacturing plants
Please select a location in "Localization" so that the address of the responsible authority can be filled in.
Costs (fees): 50 to 750 EUR (according to the schedule of costs - tariff no. 7.IX.8/ tariff item 7).
Expenses (e.g. postal delivery charges) are individual.
The costs (fees and expenses) are to be borne by the applicant.
Responsible for editing: Bayerisches Staatsministerium für Gesundheit und Pflege
- Online transactions, Bavaria-wide
- Online transactions, locally limited
- Prefillable Form, Bavaria-wide
- Legal bases, Bavaria-wide
- Legal bases, locally limited
- Fees, Bavaria-wide
- Fees, locally limited