Procedure descriptions
Registering to sell non-prescription pharmaceutical products
Certain medicines can be sold outside of pharmacies, however this must be reported.
The specific medicines are specified in more detail in the ordinance concerning medicines which must be sold in pharmacies and medicines which can be sold freely.
Responsible department
- the administrative headquarters (Regierungspräsidium) responsible for your district
- for examining your proficiency: the Chambers of Industry and Commerce (IHK)
Details
Prerequisite
As the business owner, you must demonstrate knowledge and proficiency in the following areas:
- filling
- packing
- labelling and storage
- distributing medicinal products
- Regulations which apply to the free sale of medicines.
If you personally do not have the skills required, one of the following persons must possess them:
- a person legally appointed to represent the company
- a person employed by you to manage the company, or
- a person employed by you as sales staff
Note: If you have several branches, there must be an employee available in each branch who can provide corresponding advice.
Procedure
You can provide informal notification of medicines which are sold freely. Please state the business location and the name of the expert person.
You must also register your business with the municipal council (Gemeindeverwaltung) or city council (Stadtverwaltung) responsible for the location of your future business headquarters - either in person or in writing. Depending on the authority, you can either obtain the application form there or download it from the internet.
Deadlines
You must register your intention to sell non-prescription pharmaceutical products before you actually start doing business.
Required documents
Evidence of proficiency, e.g.
- A pharmacy degree
- Completion of training as a pharmacist
- University degree in chemistry, biology, human medicine, veterinary medicine together with further proof, such as theoretical and practical tuition in certain basic subjects (§15 of the German Medicines Act - Arzneimittelgesetz)
- a final examination qualifying you as chemist assistant or commercial pharmaceutical employee
- a course of training as technical pharmaceutical assistant
- Evidence that you engaged in one of the following activities before 1978 after sitting the examination qualifying you as a commercial druggist assistant:
- at least three years of practical experience in a commercial enterprise selling non-prescription pharmaceutical products, or
- five years of administrative activity, two thereof in a managerial position, in a commercial enterprise selling non-prescription pharmaceutical products
Note: If you cannot provide this evidence, you will have to take a proficiency examination in front of the examination board of the Chamber of Commerce and Industry. For this, you will have to register at the Chamber of Commerce and Industry in the area where your place of employment, training facility or residence is located.
Costs
Costs of notification: none
You may incur further costs, e.g. for
- registering your business
- any proficiency examination you may have to take at the IHK
Miscellaneous
You must be entered in the mail order trading register.
Every mail order company that distributes pharmaceutical products in the European Union is obliged to use the common European mail order logo on its website. This shows consumers that the mail order company is entitled to distribute pharmaceutical products for human use via the internet as per the laws in the relevant country. They can also see the country in which the mail order company is located at a glance.
The logo must be clearly visible on the website. Clicking on it will forward visitors to the Register of Mail Order Companies.
Legal basis
Release note
The German original version of this text was drafted in close cooperation with the relevant departments. The Sozialministerium released it on 13.06.2019. Only the German text is legally binding. The Federal State does not assume any liability for the translated texts.
In cases of doubt or if you have any questions or problems, please contact the relevant authorities directly.
Contact
Bürger- und Standesamt (Bürgeramt)
eMail buergeramt@heidenheim.de
Telefon (0 73 21) 3 27-33 42
Fax (0 73 21) 3 23-33 32