Informative Notice
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Responsible person for launching individual lots of medicinal products
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.
Conditions
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An application for the entry in the register of persons responsible for the release of medicinal products may be submitted by applicants for the acquisition of a manufacturing authorisation and holders of a manufacturing authorisation for medicinal products in the Republic of Slovenia.
The competent authority enters the person responsible for the release of individual series of medicinal products within eight days of the receipt of a complete application, and issues a certificate thereof at the request of the applicant.
An administrative fee of EUR 4.54 must be paid for the entry in the register and issue of the certificate.
The competent authority keeps a publicly accessible register of persons responsible for the release of individual series of medicinal products.
Legal basis
- Medicinal Products Act (ZZdr-2)
- Rules on conditions for completing activities of making medicinals and determining of conditions and procedure of publishing or revocation of execution good production practices
Competent Authority
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Slovenčeva ulica 22
1000 Ljubljana -
The person responsible for the release of individual series of medicinal products must hold a second level education or level of education which as per the law complies with this level in the field of pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry, technology or biology.
The programme of education under the preceding paragraph encompasses knowledge of applied physics, general chemistry, inorganic chemistry, organic chemistry, analytical chemistry, pharmaceutical chemistry, including analysis of medicinal products, general and applied medicinal biochemistry, physiology, microbiology, pharmacology, pharmaceutical technology, toxicology and pharmacognosy.
If the study programme does not include any of the aforementioned fields, the responsible person must submit suitable certificates on additional education rendered.
In addition to the required education, the responsible person must also obtain work experience with manufacturers of medicinal products who have a manufacturing authorisation for medicinal products, of which they must have at least two years of practical experience in the field of quality analysis of medicinal products, quantitative analysis of substances, and testing and verifying for the needs of ensuring the quality of medicinal products. The period of required practical experience may be reduced by one year if the study programme is for at least five years, or by 18 months if the programme takes at least six years.
Evidence
Diploma: certified copy or non-certified copy and the original provided on request. Certificate of acquired work experience
Legal basis
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Persons responsible for the release of individual series of medicinal products must be available at all times.
Evidence
Evidence of the availability of a person responsible for the release of individual series of medicinal products
Legal basis
Recognition of qualifications acquired abroad
There are following systems for the recognition of professional qualifications acquired in the EU: