Informative Notice
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Person responsible for the acceptance, storage and transport of medicinal products and review of documentation
Wholesalers must appoint and transport medicinal products and enable the review of documentation that enables the traceability of medicinal products. The responsible person must have an appropriate education and work experience and be entered in the register of persons responsible for the acceptance, storage, issue and transport of medicinal products and the review of documentation.
Conditions
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The responsible person must hold a university degree in pharmacy.
If the responsible person does not hold a university degree in pharmacy, they must have additional knowledge as determined in the second paragraph of Article 49 of Directive 2001/83/EC or the second paragraph of Article 53 of Directive 2001/82/EC. If the study programme does not include any of the aforementioned fields, the responsible person must submit suitable certificates thereof.
The responsible person must also have work experience as determined in the third paragraph of Article 49 of Directive 2001/83/EC or the third paragraph of Article 53 of Directive 2001/82/EC.
Evidence
Diploma: certified copy or non-certified copy and the original provided on request. Certificate of additional knowledge Certificate of work experience
Legal basis
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The competent authority keeps a publicly accessible register of persons responsible for the receipt, storage, issue and transport of medicinal products and review of documentation, which includes responsible persons who meet the prescribed conditions.
The register of persons responsible for the receipt, storage, issue and transport of medicinal products and review of documentation contains the following data:
- name, surname and professional title of the person responsible for the receipt, storage, issue and transport of products and review of documentation and
- the name and address of the business entity where the tasks of the person responsible for the receipt, storage, issue and transport of medicinal products and review of documentation are implemented.
The competent authority enters the person responsible for the receipt, storage, issue and transport of medicinal products and review of documentation in the register of persons responsible for the receipt, storage, issue and transport of medicinal products and review of documentation at the request of the applicant and issues a certificate thereof.
The application for an entry, change or removal from the register under the first paragraph of this Article may be submitted by an applicant for a distribution authorisation or a holder of a distribution authorisation in the Republic of Slovenia.
Legal basis
Recognition of qualifications acquired abroad
There are following systems for the recognition of professional qualifications acquired in the EU: