Informative Notice
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Production of active ingredients
An active ingredient is any substance or a mixture of substances intended for use in the production of medicinal products which becomes in the production procedure an active ingredient in the product whose purpose is a pharmacological, immunological or metabolic effect in order to re-establish, improve or change physiological functions or to determine a diagnosis.
A producer of active ingredients must fulfil the following conditions:
- employ an adequate number of experts with adequate education, considering the scope and complexity of the production of active ingredients;
- have adequate premises, devices and equipment for the production, control, storage and transport of active ingredients in accordance with the guidelines and principles of good production practice for active ingredients;
- perform the activity in accordance with the guidelines and principles of good production practice for active ingredients.
A producer of active ingredients must be entered in the registry of producers of active ingredients, which is kept by the competent authority.
Applies for SKD:
- Manufacture of basic pharmaceutical products C21.100
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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The manufacturer of active substances with head office in the Republic of Slovenia can start performing their activity after being entered in the register of manufacturers of active substances, managed by the relevant authority.
The register of manufacturers of active substances contains the following information:
- the name of the business entity and permanent address, contact data (telephone, fax, e-mail) and
- the manufactured active substance.
The competent authority issues a certificate upon entry into the register under the first paragraph.
The manufacturers of active substances notify their activity at the relevant authority at least 60 days before starting to perform the activity, i.e. on a written application that contains evidence on fulfilling the prescribed conditions and the list of active substances they intend to manufacture.
The competent authority enters the manufacturer of active substances in the register of manufacturers of active substances on the basis of a positive opinion of the expert commission for fulfilling the conditions for the manufacture of active substances in 90 or 60 days from the date of receipt of the complete application, if they assess that the verification of the fulfilment of conditions is not necessary.
If the expert commission under the previous paragraph issues a negative opinion on the fulfilment of conditions for manufacturing active substances, the competent authority rejects the entry in the register of active substances by issuing a decision.
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The holder of the authorisation for the manufacture of medicinal products can require a confirmation or certificate on good manufacturing practice (GMP certificate) from the authority competent for medicinal products. The certificate on the implementation of good manufacturing practice can be issued based on the performed special fact-finding procedure within the scope of the authorisation issue or performed control of the fulfilment of conditions for the manufacture of medicinal products at the holder of authorisation.
The certificate on good manufacturing practice is issued by the pharmaceutical inspector to the inspected business entity ex officio within 90 days from the date of inspection, if it is found that the business entity manufactures medicinal products or active substances in accordance with the good manufacturing practices principles and guidelines or within 15 days from the issue of modification of the authorisation for manufacturing medicinal products or the entry or the modification of the entry in the register of manufacturers of active substances.
The certificate on good manufacturing practice is issued on a form in Slovenian and English languages as stipulated in the Compilation of Community Procedures.
The certified application lodged by the holder of the authorisation contains:
- full and short name and address of the applicant;
- the number of the authorisation for manufacturing medicinal products;
- location and activity from the authorisation for which the applicant requests a certificate;
- the number of existing certificates for such activities.
The certificate contains only the information on the conformity of the applicant's activities in the scope of the supervision which is the basis for the issue of the certificate.
The validity of the certificate is usually three years. The validity can be shortened based on the opinion of the pharmaceuticals supervisor.
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The manufacturer of active substances must within seven days notify the relevant authority on any modification of conditions that the manufacturer of active substances for the entry in the register of manufacturers of active substances must fulfil (appropriate staff, premises, devices and equipment, the consideration of good manufacturing practice guidelines), i.e. which has an important impact on the quality or safety of the manufactured active substance.
The competent authority enters the notified change in the register of manufacturers of active substances:
- based on the opinion of the expert committee on establishing the fulfilment of conditions for the manufacture of active substances in 90 days by issuing a certificate
- or entering the change under the previous paragraph in the register of manufacturers of active substances in 30 days from the date of the receipt of the complete application if the committee assesses that the verification of the fulfilment of conditions is not necessary and issues an appropriate certificate.
If the change under the first paragraph of this article does not refer to data from the register of manufacturers of active substances, the competent authority issues a decision on the assessment of the fulfilment of conditions for manufacturing active substances in 30 days or in 90 days from the date when a complete application is received, if the committee assesses that the verification of the fulfilment of conditions is required.
If the expert commission under the previous paragraph issues a negative opinion on the change of the fulfilment of conditions for manufacturing active substances, the competent authority does not enter it in the register of active substances by issuing a decision.
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The manufacturer of substances informs the competent authority and the marketing authorisation holder about
- counterfeit substances or
- suspicion thereof immediately after becoming aware of this.
Legal basis
Competent Authority
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Slovenčeva ulica 22
1000 Ljubljana -
The manufacturer of substances must include in the annual report all other changes of conditions which it failed to report as important during the year and which refer to the conditions serving as the basis for entry in the register.
The report is submitted to the competent authority no later than by 15 December of the current year, i.e. for all changes in the current year. The competent authority enters the changes within 30 days from the date of receipt of a complete report if the change of data in the register of manufacturers is concerned, and issues a certificate thereof.
Legal basis
Competent Authority
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Slovenčeva ulica 22
1000 Ljubljana