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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.

Conditions

These terms apply to activity Production of medicinal products

  • Relating to the scope and complexity of production, the manufacturer of medicinal products must employ a suitable number of experts with second level education or the level of education which as per the law complies with this level in the field of pharmacy, chemistry, chemical technology, medicine, dental medicine, veterinary medicine and other suitable fields with appropriate knowledge relating to the business field.

    A manufacturer of a medicinal product:

    • ensures a sufficient number of responsible and suitably qualified staff for the provision of quality at every production site;
    • defines the tasks and responsibilities of the managing and supervisory staff and also of persons responsible for the establishment and implementation of good production practice in job descriptions, and displays their hierarchical relationships in the organisational scheme; organisational schemes and job and task descriptions are confirmed in accordance with the internal procedures of the manufacturer.

     The staff referred to in the preceding paragraph must hold suitable authorisations to carry out their duties within the quality assurance system.

    The manufacturer of medicinal products enables their staff initial and further education, which particularly includes the theory and application of the concept of providing quality and good production practice, and when necessary also special requirements for the production of medicinal products subject to trials. The efficiency of the educational system is regularly verified.

    The manufacturer of medicinal products establishes, manages and updates hygienic programmes adjusted to activities being implemented. These programmes particularly include procedures referring to the health, hygienic practice and work clothing of staff.

    Legal basis

  • The producer of medicinal products must conclude a contract with a responsible person who is qualified for launching an individual lot of a medicinal products and is constantly available. In the case of associated companies, this person can have a contract concluded with one of them if the delimitation of responsibilities and competences of individual units is legally and organisationally arranged. The responsible person for launching individual lots of medicinal products must have appropriate education and work experience and be entered in the register of responsible persons for launching medicinal products.

    Details

  • The manufacturer of medicinal products must ensure that persons responsible for the release of individual series of medicinal products perform their tasks independently, and provide sufficient funds for the implementation of tasks.

    Evidence

    Written statement of the applicant to ensure persons responsible for the release of individual series of medicinal products perform their tasks independently and that sufficient funds are provided

    Legal basis

  • The manufacturer of medicinal products must ensure that production procedures are conducted in accordance with the principles and guidelines of good manufacturing practice. This provision also applies to medicinal products intended for export or removal from the market.

    The principles and guidelines of good manufacturing practice include:

    •  A quality assurance system;
    • appropriate staff;
    • appropriate premises and equipment;
    • suitable documentation;
    • suitable production procedures;
    • quality control;
    • suitably arranged contract work;
    • complaints, product recall and emergency unblinding;
    • internal control;
    • labelling of medicinal products for clinical trial;
    • keeping records on medicinal products used in veterinary medicine -
    which are described in more detail in the Rules on conditions for completing activities of making medicinals and determining the conditions and procedure of publishing or revoking the execution of good production practices and in the publication, “The Rules Governing Medicinal Products in the European Union, Volume 4 – Good Manufacturing Practices, Medicinal Products for Human and Veterinary Use, 1998 Edition, European Commission, Directorate General III – Industry, Pharmaceutical and Cosmetics” with all amendments.

    Evidence

    Certificate of good manufacturing practice

    Legal basis

    Competent Authority

  • The manufacturer of medicinal products verifies the compliance of producers and suppliers of substances with good manufacturing practice for substances or good distribution practice for substances, or both, by conducting assessments.

    Legal basis

Last modified:
8. 9. 2021