Informative Notice
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Production of excipients for medicinal products
An excipient is any ingredient of a medicinal product which is not an active ingredient or a capsule.
Business entities which produce excipients perform the production in accordance with the guidelines and principles of good production practice for excipients which are adopted and published by the European Commission.
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 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