Informative Notice
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Preparation of non-routine medicinal products for advanced therapy
- performs health-care services, with the provider having the exclusive professional liability in accordance with an individual order for an individual non-routinely prepared medicinal product for advanced therapy for an individual patient,
- or which performs veterinary services, with the provider having the exclusive professional liability in accordance with an individual order for an individual animal or a group of animals from the same holding.
A business entity which prepares non-routinely prepared medicinal products for advanced therapy must fulfil the following conditions:
- employ an adequate number of experts with adequate education, considering the scope and complexity of preparation of non-routinely prepared medicinal products for advanced therapy;
- have adequate premises, devices and equipment for the preparation, control, storage and transport of non-routinely prepared medicinal products for advanced therapy;
- appointing a person among the expert staff responsible for quality of non-routinely prepared medicinal products for advanced therapy who is responsible for ensuring that the preparation of non-routinely prepared medicinal products for advanced therapy is carried out in accordance with the existing legislation;
- have a quality system which is regularly updated within reason, considering the principles and guidelines of good production practice;
- take into account the specific characteristics of a non-routinely prepared medicinal product for advanced therapy; consider the produced risk assessment and ensure the minimum standards determined in the Republic of Slovenia with regulations on the supply of human tissue and cells intended for treatment;
- have adequate contracts concluded with business entities which supply materials and services which affect the quality and safety of non-routinely prepared medicinal products for advanced therapy in which the responsibilities, tasks and professional expertise of all contractual parties are precisely defined;
- in accordance with good distribution practice, provide adequate transport for transporting non-routinely prepared medicinal products for advanced therapy to the client.
In the preparation and use of non-routinely prepared medicinal products for advanced therapy which contain or are made of human tissue or cells, complete traceability from the donor to the recipient must be ensured.
A non-routinely prepared medicinal product for advanced therapy in human or veterinary medicine may be prepared by a business entity which holds a permit from the competent authority for the preparation of a non-routinely prepared medicinal product for advanced therapy in accordance with the quality standards or conditions for preparation determined by the relevant law, within the limits of the issued permit.
A non-routinely prepared medicinal product for advanced therapy is prepared on the basis of an individual written order from a physician or veterinarian, which is a type of medical or veterinary prescription with which a physician or veterinarian prescribes a non-routinely prepared medicinal product for advanced therapy for the treating a patient or animal at a health-care or veterinary care service provider.
A holder of a permit for the preparation of a non-routinely prepared medicinal product for advanced therapy must not:
- prepare non-routinely prepared medicinal products for advanced therapy which are not covered by the permit for the preparation of non-routinely prepared medicinal products for advanced therapy;
- prepare non-routinely prepared medicinal products for advanced therapy at locations and in facilities which are not listed in the permit for the preparation of non-routinely prepared medicinal products for advanced therapy;
- prepare non-routinely prepared medicinal products for advanced therapy in premises which are not listed in the documentation which was the basis for issuing the permit for the preparation of non-routinely prepared medicinal products for advanced therapy;
- perform other activities on the same premises if it has failed to obtain consent from the competent authority;
- prepare non-routinely prepared medicinal products for advanced therapy which contain human tissue or cells if the donation and acquisition of human tissue and cells and the testing of donors of human tissues and cells was not performed in accordance with the existing regulations;
- prepare non-routinely prepared medicinal products for advanced therapy for the purpose of clinical testing.
Applies for SKD:
- Manufacture of pharmaceutical preparations C21.200
Conditions
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Applicants who wish to pursue this activity must register the business activity, and have the appropriate legal status.
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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.
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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 -
Evidence
Certificate of good manufacturing practice
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 business entity must conclude suitable contracts with business entities providing materials and services which affect the quality and safety of non-routinely prepared advanced therapy medicinal products and which minutely determine the responsibilities, tasks and expert qualifications of all contracting parties.
Legal basis
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In accordance with good distribution practice, the business entity ensures the suitable transport of non-routinely prepared advanced therapy medicinal product to the client.
Legal basis
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The business entity must use materials and reagents whose quality complies with the principles and guidelines of good manufacturing practice; if these are not determined, then on the basis of an expert substantiation of materials and reagents of the highest quality.
Legal basis
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The business entity must establish a risk management system which observes the principles and guidelines of good manufacturing practice by analogy, while considering the specific characteristics of non-routinely prepared advanced therapy medicinal products and the prepared risk assessment, and ensures at least the standards which are determined by the regulations governing the supply of human tissues and cells intended for treatment in the Republic of Slovenia.
Legal basis
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The business entity ensures that all tests necessary to confirm compliance with specifications and standards are implemented on samples of starting materials and final non-routinely prepared advanced therapy medicinal products or intermediate products.
The client is issued a certificate of compliance of the preparation of the non-routinely prepared advanced therapy medicinal product with the specifications and standards guaranteed by the marketing authorisation holder.
Legal basis
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With due diligence, the business entity ensures that all data on starting materials, intermediate products and final non-routinely prepared advanced therapy medicinal products, including data on the compatibility of individual components of a multi-component non-routinely prepared advanced therapy medicinal product and packaging, which are observed in the assessment of safety, quality and efficiency, are true and not misleading.
Legal basis
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The business entity must ensure that data on starting materials, intermediate products and final non-routinely prepared advanced therapy medicinal products and all recorded details of the preparation of the non-routinely prepared advanced therapy medicinal product are stored in a form which is accessible and readable at least 30 years after the use of the non-routinely prepared advanced therapy medicinal product.
Legal basis
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By 31 January of the current year, the holder of a licence for the preparation of non-routinely prepared advanced therapy medicinal products must submit an annual report on its activities for the past year to the competent authority, which includes the following data:
- number of non-routinely prepared advanced therapy medicinal products;
- non-routinely prepared advanced therapy medicinal products from the group of advanced therapy medicinal products for which the Agency of the Republic of Slovenia for Medicines and Medical Devices (JAZMP) has issued an authorisation;
- number of patients or animals treated with an individual non-routinely prepared advanced therapy medicinal product;
- name of the doctor or veterinarian who prescribed the non-routinely prepared advanced therapy medicinal product and who is responsible for monitoring the patient or the animal, and the name of the donor centre.
Legal basis
Competent Authority
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Slovenčeva ulica 22
1000 Ljubljana -
A non-routinely prepared advanced therapy medicinal product must be labelled accordingly and equipped with instructions for use in a way that enables its traceability and correct and safe use.
Legal basis
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Advertising non-routinely prepared advanced therapy medicinal products, the preparation of non-routinely prepared advanced therapy medicinal products or treatment with non-routinely prepared advanced therapy medicinal products is prohibited.
Legal basis