Informative Notice
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Licence for the preparation of a non-routinely prepared medicinal product
A business entity with its head office in the Republic of Slovenia can only prepare non-routinely prepared advanced therapy medicinal products based on and in accordance with the licence for the preparation of non-routinely prepared advanced therapy medicinal products, issued by the relevant authority.
The procedure for the issue of the licence for non-routinely prepared advanced therapy medicinal products is initiated with an application submitted by the applicant with its head office in the Republic of Slovenia, i.e. for the preparation of an individual type of non-routinely prepared advanced therapy medicinal products, separately for:
- medicinal products for genetic treatment,
- medicinal products for somatic cell treatment and
- tissue engineering products by indicating individual medicinal products in the group.
Conditions
These terms apply to activity Preparation of non-routine medicinal products for advanced therapy
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The business entity must employ a suitable number of experts with appropriate education relating to the extent and complexity of preparing a non-routinely prepared medicinal product for advanced therapy.
Legal basis
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The business entity must have suitable premises, devices and equipment for the preparation, control, storage and transport of a non-routinely prepared medicinal product for advanced therapy.
Legal basis
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The business entity establishes a quality system and updates it.
Legal basis
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A business entity that produces non-routinely prepared medicinal products, must appoint a person responsible for the quality of non-routinely prepared advanced therapy medicinal products for progressive treatment, who is responsible that the preparation of the non-routinely prepared advanced therapy medicinal product is in accordance with the valid regulations.
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A holder of a licence for preparation of non-routinely prepared advanced therapy medicinal products establishes and maintains a system ensuring the traceability of non-routinely prepared advanced therapy medicinal product and starting materials, including materials which come into contact with tissues and cells which the non-routinely prepared advanced therapy medicinal products may contain - from source, preparation, packing, storage and transport to the provider of medical or veterinary services where the non-routinely prepared advanced therapy medicinal product is used.
The holder of a licence for the preparation of non-routinely prepared advanced therapy medicinal products must store data on traceability for at least 30 years after the expiry date of the non-routinely prepared advanced therapy medicinal product.
The holder of a licence for the preparation of non-routinely prepared advanced therapy medicinal products must ensure that data on traceability are available to the competent authority also in the case of the withdrawal, revocation or termination of this licence. In the event of bankruptcy or cessation of business activities, the data on traceability must be submitted to the competent authority.
The holder of the licence for the preparation of non-routinely prepared advanced therapy medicinal products must ensure that the traceability system of a non-routinely prepared advanced therapy medicinal product which contains human tissue and cells meets, and is compliant with, the requirements of Articles 8 and 14 of Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L 102, 7 April 2004, p. 48) as last amended by Regulation 596/2009/EC and Article 14 and 24 of Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 on setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 33, 8 February 2003, p. 30) as last amended by Regulation 596/2009/EC.
Legal basis
- Medicinal Products Act (ZZdr-2)
- Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (2004/23)
- DIRECTIVE 2002/98/EC OF THE EUROPEANPARLIAMENTANDOF THE COUNCILof 27 January 2003setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/E
Competent Authority
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Slovenčeva ulica 22
1000 Ljubljana -
Pharmacovigilance denotes the monitoring of the safety of medicinal products after the acquisition of marketing authorisation, and includes all activities related to the detection, assessment, understanding and prevention of the adverse effects of medicinal products and other medicinal product-related complications.
Activities in the field of pharmacovigilance:
- collection and assessment of reports on the adverse effects of medicinal products and reporting in the pharmacovigilance system;
- assessment of periodic safety update reports (PSUR);
- assessment of other data related to the safety of medicinal products;
- risk assessment, adoption and implementation of measures for the safe use of medicinal products;
- assessment of plans for risk management and detailed descriptions of the pharmacovigilance system;
- informing of the expert and broader public;
- activities in the international system of pharmacovigilance;
- implementation of pharmacovigilance control at holders of marketing authorisations and
- encouraging health-care workers to report the adverse effects of medicinal products.
The holder of the marketing authorisation for medicinal products for human use:
- establishes, maintains and manages the pharmacovigilance system, which ensures the collection and keeping of documentation about all the assumed adverse effects of medicinal products in the European Union and third countries, scientifically assesses all information, studies options for the reduction and prevention of risk, adopts necessary measures and exchanges data with authorities responsible for medicinal products in the EU member states;
- regularly assesses its own pharmacovigilance system and keeps a main dossier on the pharmacovigilance system, which it submits to the competent authority on request;
- manages a risk management system for all medicinal products and updates it proportionately with the established risks and monitors data on pharmacovigilance;
- informs the authority competent for medicinal products in the Republic of Slovenia of newly established or changed risks, on changes in the relationship between the benefits and risks of medicinal products and, in advance or simultaneously, informs the authority competent for medicinal products in the Republic of Slovenia, the European Commission and the European Medicines Agency (EMA) on the content of every publication of information relating to questions about pharmacovigilance;
- immediately submits all data proving that the relationship between benefit and risk remains beneficial at the request of the competent authority;
- meets the requirements and obligations relating to the supervision of non-interventional studies on the safety or efficiency of medicinal products after the acquisition of a marketing authorisation as per this act;
- submits data on all the assumed adverse effects of medicinal products into the EudraVigilance database with the exception of reports on medicinal products with substances from the list of publications monitored by the EMA;
- fulfils obligations relating to periodic safety update reports on medicinal products as per the first and third paragraphs of Article 107.b and the first, second, third and sixth paragraphs of Article 107.c of Directive 2001/83/EC;
- observes procedures during the implementation of pharmacovigilance which are described in detail in implementing measures of the European Commission as per Article 108 of Directive 2001/83/EC, the guidelines on good practices in the field of pharmacovigilance as per Article 108.a of Directive 2001/83/EC and scientific guidelines on efficiency studies after the acquisition of a marketing authorisation as per Article 108.a of Directive 2001/83/EC.
The holder of the marketing authorisation for medicinal products for human use must employ a person responsible for the pharmacovigilance system.
If the marketing authorisation holder does not have its head office in the Republic of Slovenia, it may also appoint, in addition to the person responsible for the pharmacovigilance system, a contact person for pharmacovigilance in the Republic of Slovenia who has a secondary level of education in medicine, veterinary medicine or pharmacy or another compliant level of education as per the law and who is suitably qualified. The contact person for pharmacovigilance must also be appointed if this is requested by the competent authority which issues a decision in this regard. The contact person may be a business entity with its head office in the Republic of Slovenia or an individual with permanent or temporary residence in the Republic of Slovenia who performs pharmacovigilance activities for the needs of one or several business entities.
The provision of pharmacovigilance services is defined in more detail in the Rules on the pharmacovigilance of medicinal products for human use.
Legal basis
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The holder of the marketing authorisation must have a permanently available person responsible for the pharmacovigilance system who is responsible for the establishment and maintenance of the pharmacovigilance system. The person responsible for pharmacovigilance system:
is responsible for the establishment and maintenance of the pharmacovigilance system to ensure the collection and comparison of data on all suspected adverse reactions of the medicinal product; has ensured access to the main dossier on the pharmacovigilance system and sufficient jurisdiction for ensuring that the content of the main dossier on the pharmacovigilance system is accurate and regularly updated to reflect the needs of the pharmacovigilance system; has sufficient jurisdiction to impact the implementation of the quality system and pharmacovigilance activities; has an overview of the safety profiles of medicinal products and safety issues and considers as well as monitors the conditions of launching medicinal products and other obligations that affect the safety of medicinal products and the measures for reducing risks; has sufficient jurisdiction with regard to the content of risk management plans, cooperates at the review and approval of protocols of clinical trials after acquiring the marketing authorisation; ensures appropriate quality, accuracy and completion of data on the pharmacovigilance of the medicinal product that are submitted to the competent authority and to all requirements of the competent authority to submit additional data required for assessing benefits and risks connected with the medicinal product, replies in entirety and immediately and submits data on sales; submits all other information relevant for the assessment of benefits and risks connected to the medicinal product to the competent authority, including appropriate data from clinical trials after obtaining the marketing authorisation; guarantees 24-hour availability; has appropriate education, knowledge and skills.
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The business entity must obtain a positive opinion from the Republic of Slovenia National Medical Ethics Committee (NMEC) for the preparation of an individual group of medicinal products for human use, i.e. separately for:
- gene therapy medicinal products,
- somatic cell therapy medicinal products and
- tissue engineered products.
The opinion is obtained on the basis of an application prepared as per the instructions published on the website of the NMEC and then submitted to the NMEC.
The issuing of the NMEC’s opinion is conducted on the basis of procedures determined in the Rules of Procedure of the Republic of Slovenia National Medical Ethics Committee.
Legal basis
Procedures
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Licence for the preparation of a non-routinely prepared medicinal product
Attachments
- Evidence of fulfilment of conditions to ensure the quality of the system, personnel premises, equipment, traceability and the pharmacovigilance system
- List of routinely prepared advanced therapy medicinal products from the group of advanced therapy medicinal products to which the application refers
- Description of preparation procedures of groups of advanced therapy medicinal products, which includes information on risk factors such as information on the origin and properties of cells, type of cell manipulation and the manner of use
- Positive opinion of the Medical Ethics Committee on the group of advanced therapy medicinal products in question for human use to which the application refers