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    Activity licences

    26.04.2017
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    An activity licence must be granted by the State Agency of Medicines for:

    • Handling of medicinal products (including human medicinal products, veterinary medicinal products, herbal medicinal products, medicinal products for clinical trials, active substances of medicinal products, whole blood and blood components):

    - Manufacturing of medicinal products
    - Wholesale distribution of medicinal products
    - Pharmacy services

    • Brokering of human medicinal products

     

    Application for activity licences for handling and brokering of medicinal products

    Procedures related to activity licences for handling and brokering of medicinal products are regulated by the General Part of the Economic Activities Code Act and Division 6 “Activity Licence for Handling and Brokering of Medicinal Products” of the Medicinal Products Act.

    Each general pharmacy, veterinary pharmacy, hospital pharmacy, or a place of business for wholesale distribution or manufacturing of medicinal products must have a separate activity licence.

    An application must be submitted to the State Agency of Medicines for:

    • issuing of activity licences;
    • amendment of activity licences.

    Please submit your application electronically or through the Client portal of the State Agency of Medicines.

    The application for an activity licence should be submitted sufficiently in advance, considering the time limit set for its processing.

    Application forms:

    Application for an activity licence for general pharmacy
    Application for an activity licence for hospital pharmacy
    Application for an activity licence for veterinary pharmacy
    Application for an activity licence for wholesale distribution
    Application for an activity licence for manufacturing of medicinal products
    Application for an activity licence for brokering of medicinal products

    For re-labelling and secondary re-packaging, please use the application for an activity licence for manufacturing of medicinal products. In section 7. „ACTIVITIES – specific information on medicinal products“ please indicate „secondary packaging“ under item 1.5 „Packaging“, and add clarifications if necessary. There is a separate sub-section for investigational medicinal products.

    For manufacturing of blood components and handling of herbal substances, please use the application for an activity licence for manufacturing of medicinal products. At the top of section 7. „ACTIVITIES“  please indicate „blood components“ or „herbal substances“. Other sub-items of section 7 do not need to be filled in.

    The application for the handling of medicinal products must be signed (in addition to the applicant for the activity licence) by a competent person designated at the place of business. The main requirements and responsibilities of a competent person are specified in Division 7 “Competent person” of the Medicinal Products Act. The qualification criteria are set forth in the Minister of Social Affairs Regulation No. 42 of 11 March 2005 “Requirements for Qualifications of Competent Persons and List of Evidence of Formal Qualification”.

    The application for an activity licence must be submitted with accompanying documents listed in the Medicinal Products Act: subsections 46 (2) to (7),
    and in the General Part of the Economic Activities Code Act: clauses 15 (2) 3) and 4) [specified further in section 2 of the regulation “Requirements for Qualifications of Competent Persons and List of Evidence of Formal Qualification”] and clause 19 (2) 4) [and 5) - for the broker of a medicinal product, if relevant] and in subsection (4).

    The applicant must pay the state fees.

     

    The decision of the State Agency of Medicines and the activity licence

    The State Agency of Medicines makes its decision on granting an activity licence within 60 days after the submission of all required documents. If a voluntary revocation of an activity licence is applied for, the decision is made at the earliest opportunity.

    The time limit of the decision is extended (by up to 30 days), if the State Agency of Medicines sets a term for:

    • the submission of a suitable application or documents;
    • the elimination of essential deficiencies hindering the granting of an activity licence;
    • providing clarifications.

    If an application or documents are submitted, deficiencies are eliminated and explanations are provided before the end of term, the term of processing is concluded with the submission of documents, elimination of deficiencies or provision of explanations.

    If a suitable application or documents are not submitted to the State Agency of Medicines within the set term, the State Agency of Medicines can refuse processing the application.

    Before making its decision, the State Agency of Medicines checks, within the limits of its competence, the compliance of the conditions of the place of business, the activity of the applicant of the activity licence, and also the staff, if necessary, with the requirements in force. The inspection is mostly executed in the place of business, but the State Agency of Medicines can also use other results and measures of supervision. Please bear in mind that the place of business must meet the requirements in force at the time of processing of the application for an activity licence – otherwise, the State Agency of Medicines cannot determine its suitability and the processing of the application shall be suspended until a term set by the State Agency of Medicines, during which the place of business must be brought into compliance with requirements.

    The applicant is asked for additional clarifications or a term is set for elimination of essential deficiencies hindering the grant of an activity licence, if necessary.

    An application for an activity licence can be satisfied, if the applicant for an activity licence, the place of business, and the activity of an applicant, on the basis of an activity licence issued earlier, meet the requirements in force.

    The State Agency of Medicines satisfies the application for an activity licence in the absence of grounds for refusal to grant an activity licence as set forth in Section 25 of the General Part of the Economic Activities Code Act. Activity licences are granted without a term, unless an applicant requests an activity licence to be issued for a specified term. On the third working day as of the making of the decision at the latest, the State Agency of Medicines forwards to the applicant the decision on the satisfying or refusal to satisfy an application for an activity licence for the handling or brokering of medicinal products, and the activity licence issued for handling of medicinal products. 

    The owner of an activity licence has:

    • the right to operate in accordance with the procedure and on the conditions provided by the Medicinal Products Act and legislation established on the basis thereof in the area of activity, place of business and on the conditions set out in the activity licence.
    • the obligation to comply with requirements set forth in section 44 (manufacturing and wholesale of medicinal products), section 45 (provision of pharmacy services) and subsection 26 (81) and (82) (brokering of medicinal products) of the Medicinal Products Act. The holder of an activity licence is always liable for the assurance of proper handling of medicinal products.
    • to consider the limitations set forth in sections 42 and 43 of the Medicinal Products Act.

     

    Public disclosure of activity licences for the handling and brokering of medicinal products

    Information concerning the activity licence shall be available at the Activity Licence Register from its effective date. Activity licences for the wholesale and manufacturing of medicinal products are additionally available in the EudraGMDP database.

     

    Annex 1

    Documents and information required when applying for an activity licence for pharmacy services

    (Grounds: Section 46 of the Medicinal Products Act, Clauses 15 (2) 3) and 4) of the General Part of the Economic Activities Code Act and section 19, and section 2 of the Minister of Social Affairs Regulation No. 42 of 11 March 2005 “Requirements for Qualifications of Competent Persons and List of Evidence of Formal Qualification”)

    1. ISSUING OF AN ACTIVITY LICENCE
    Application on the form published on the website of the State Agency of Medicines

    Proof of payment of state fees

    Copy of the instrument of incorporation or foundation resolution of a company (in case of a legal person not entered in the business registry)

    Document certifying the right of use of the premises (+ branch pharmacies)

    Layout and description of the premises of the place of business (+ branch pharmacies)

    Description of the technical equipment (+ branch pharmacies)

    Description of the storage of medicinal products (+ branch pharmacies)

    Arrangements for the quality control of medicinal products (+ branch pharmacies)

    Documents regarding the Head of pharmacy:

    - Copy of a document certifying education

    - Copy of a document certifying the change of name (if relevant)

    - Document certifying the career or a CV (workplaces and periods of employment, fields of activity)

    - List of completed in-service trainings

    List of professional employees (name, position, professional experience) (+ branch pharmacies)

    When applying for the first time – the planned number of professional employees (pharmacists, assistant pharmacists)

    A confirmation that there have been no changes to the documents submitted earlier (all must be listed separately!)


    2. APPLICATION FOR AMENDMENTS TO AN ACTIVITY LICENCE
    Making amendments to a valid activity licence (e.g. opening a branch pharmacy, change of business name, replacement of the Head of pharmacy, change of the location or name of pharmacy, etc.)

    Application on the form published on the website of the State Agency of Medicines

    All documents listed in section 1 relevant to the amendment applied for

    Documents on the organisation of distance selling of medicinal products, if the right of distance selling of medicinal products is applied for

    A confirmation that there have been no changes to the documents submitted earlier (all must be listed separately!)