Conformity assessment procedures must generally be carried out for products in potentially explosive areas. You can apply for approval in justified exceptional cases.
To export a medicinal product approved in Germany to a country outside the EU, you need a certificate issued in accordance with the recommendations of the World Health Organization (WHO).
If you wish to import medicinal products, certain active ingredients or investigational medicinal products for clinical trials into Germany from countries outside the EU or the European Economic Area for professional or commercial purposes, you ...
If you operate a pharmaceutical company that markets finished medicinal products, you must notify the competent authority of a person responsible for information. You must also notify any changes concerning this person immediately.
If you operate a pharmaceutical company that markets finished medicinal products, you must notify the competent authority of a qualified person. You must also notify them immediately of any changes to the qualified person.
