Authorisation for manufacturing medicinal products that includes analytical testing of medicinal products

The medicinal products are analysis-tested by business entities with the authorisation for manufacturing medicinal products that also includes analytical testing of medicinal products.

Examiners must fulfil the conditions for acquiring the authorisation for analytically testing medicinal products, i.e. with regard to staff, premises, equipment and good practices principles determined in the regulation that determines specific conditions for manufacturing medicinal products and establishing the fulfilment of these conditions and on the procedure of publishing or withdrawing the certificate on the implementation of good manufacturing practice.

The authorisation for analytically testing medicinal products is issued within the authorisation for manufacturing medicinal products.

Detailed instructions which the medicine examiners for analytical testing of medicinal products must fulfil are published in the Rules governing medicinal products in the European Union, Volume 4 – Good manufacturing practice, including all amendments adopted by the European Commission which are published on the Eudralex website.

The authorisation includes the manufacture of medicinal products and their sale to wholesalers of medicinal products and must be acquired for:

  • individual manufacturing sites,
  • individual manufacturing activities,
  • individual pharmaceutical forms
  • and the import of medicinal products from third parties.

 The application for the acquisition of the authorisation for manufacturing medicinal products is submitted by the application to the agency in printed and electronic form.

The general part of the application encompasses the following data and documents:

Letter indicating:

 - the full and shortened name and head office of the applicant, stating all locations where medicinal products are manufactured;

- activities of the applicant subject to the procedure for the issue of the authorisation for manufacturing medicinal products;

- name and surname of the responsible person and signature of the responsible person;

Documentation:

- the list of persons who work as manufacture and control managers or other persons who take over responsibilities determined in the second chapter of good manufacturing practice;

- evidence on the availability of the person responsible for launching an individual lot of medicine and who is constantly accessible and fulfils the prescribed conditions, evidence on their professional education and appropriate work experience;

- written statement of the applicant to enable the responsible person under the previous item independent performance of duties and that it has all required means;

- written statement of the applicant that they will manufacture medicinal products in accordance with the guidelines and principles of good manufacturing practice;

- written statement of the applicant that they will use only active substances manufactured in accordance with good manufacturing practice;

- written statement of the applicant that only medicinal products manufactured within the activities under the manufacture authorisation will be ensured in accordance with regulations.

The expert part of the application contains information from the applicant on fulfilling expert requirements. The applicant states information in the scope that applies to the scope of their work processes for the manufacture of medicinal products.

The expert part of the application can be replaced by an appropriate internal document of the applicant which contains the prescribed data.

The applicant states data and documents in the expert part which are determined in the Annex to the Rules on conditions for completing activities of making medicinals and determining of conditions and procedure of publishing or revocation of execution of good production practices.

Legal protection

  • Judicial remedy: Appeal
  • Competent authority: Ministry of Health
Last updated: 10. 02. 2016