Authorisation for manufacturing medicinal products

A business entity can produce medicinal products only on the basis and in accordance with the authorisation for manufacturing medicinal products. 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 provisions under the previous paragraph apply also for the manufacture of medicinal products that are intended for removal, export or clinical tests of medicinal products.

The manufacturer of the medicine must fulfil the following conditions:

• considering the scope and complexity of medicine manufacture, the manufacturer employs a suitable number of experts with the required education;
• has a concluded contract with a responsible person who is qualified for launching an individual lot of medicine into the market and is constantly available;
• disposes of appropriate premises, devices and the equipment for the manufacture, control, storage and dispatch of medicinal products in accordance with guidelines and principles of good manufacturing practice for medicinal products;
• manufactures medicinal products in accordance with guidelines and good manufacturing practice for medicinal products and uses active substances manufactured in accordance with good manufacturing practice for active substances that were traded in accordance with good distribution practice for active substances;
• and enables the responsible person under item 2 independent performance of tasks with all necessary available means.

The procedure for the acquisition of the authorisation for the manufacture of medicinal products starts on the basis of the application of a legal or natural entity encompassing the general and expert part.

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 manufacturing 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 on 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.