Informative Notice
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Brokerage in wholesale of medicinal products and active ingredients
Agents in wholesale medicinal products and substances must:
- meet the requirements of good distribution practice for activities referring to brokerage;
- establish a traceability system for medicinal products or substances which enables support for the recall of a medicinal product or a substance;
- keep suitable documentation on the placement of medicinal products and substances;
- maintain a quality system, with clearly defined responsibilities and described procedures and a described method of risk management referring to relevant activities;
- ensure that medicinal products subject to placement have marketing authorisations or exceptional temporary marketing authorisations;
- verify and cooperate only with providers of medicinal products (manufacturers, importers, wholesalers) who meet the requirements of good manufacturing or distribution practice and operate in accordance with the regulations governing medicinal products or substances;
- inform the competent authority about counterfeits or suspected counterfeiting of medicinal products or substances immediately they become aware of the aforementioned, and
- keep documentation on the brokerage of medicinal products or substances which is available to the competent authority for inspection and store it for a least five years.
Applies for SKD:
- Agents specialised in the sale of other particular products G46.180
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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Business entities with head offices in the Republic of Slovenia performing as agents in the wholesale of medicinal products or substances, must notify the relevant authority on the activity before the start of the activity, i.e. for entry in the public register of agents selling medicinal products and substances.
The competent authority issues a certificate on the entry in the register of agents selling medicinal products and substances.
The notification for the entry in the register of agents selling medicinal products and substances must contain the following data:
- name and head office of the business entity,
- contact data (contact person, telephone, fax, e-mail).
The agents selling medicinal products and substances must notify the relevant authority on any modification of data, subject to the entry in the register under the first paragraph of this article.
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Quality assurance system Wholesalers must establish, implement and update an efficient quality assurance system for all their business activities by actively involving the management and staff of internal organisational units in the quality assurance system.
Staff
Wholesalers must meet the following conditions relating to their staff:
- employ a number of contractually bound experts with a university degree in pharmacy suitable to the extent of the activities and nature of the work process and contractually bound experts of other suitable education;
- employ a person responsible for the receipt, storage, issue and transport of medicinal products and for reviewing documentation enabling the traceability of medicinal products. The responsible person must meet the prescribed conditions.
The wholesaler is obliged to enable continuous education and training for its staff, particularly the responsible person.
Premises and equipment
When implementing their activities, wholesalers must have at their disposal suitable premises and equipment as per the principles of good distribution practice and principles of good storage practices.
Documentation
Wholesalers must establish, conduct and update written procedures relating to the entire distribution process, and keep records on the provision of conditions for the distribution of medicinal products (calibration, equipment qualification, validation, cleaning and maintenance of premises etc.).
Wholesalers must keep records and documentation as per the preceding paragraph in a way that enables the immediate recall of a medicinal product and supervision of complaints. All handling of the medicinal product must be recorded to ensure the traceability of the product.
The documentation referred to in the preceding paragraph must contain at least:
- the date of each prescription or issue of the medicinal product; name of the product, pharmaceutical form, strength and presentation;
- serial number of the product and expiry date;
- quantity of the received or issued product; name and address of the manufacturer;
- quality analysis results and release date of each series of the medicinal product;
- name and address of the supplier;
- name and address of the recipient;
- name and address of the company responsible for transporting the medicinal product.
The wholesaler must store the documentation referred to in the preceding paragraph for at least one year after the expiry date or recall of the medicinal product or longer if this is required by the prescribed principles of good distribution practice.
Wholesalers of medicinal products used in veterinary medicine and medicinal products for human use in the case of exceptional use in veterinary medicine must submit quarterly reports to the Veterinary Administration of the Republic of Slovenia.
The reports referred to in the preceding paragraph must include at least:
- the quantity of medicinal products issued for each individual medicinal product;
- individual recipients, with the provision of data on the period to which the report refers and
- the name of the person responsible for conducting transactions with medicinal products.
The reports must be submitted in an electronic form whose standard is determined by the Veterinary Administration of the Republic of Slovenia.
The wholesaler must establish, verify and update written procedures as per the principles of good distribution practice.
Legal basis
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A business entity must establish a traceability system for medicinal products or substances which enables support for the recall of a medicinal product or a substance.
Legal basis
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Open section: Close section: Keeping documentation on the placement of medicinal products/substances
A business entity must keep suitable documentation on the placement of medicinal products and substances.
The documentation must be kept for at least five years for the needs of inspection supervision by the competent authority.
Legal basis
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A business entity must maintain a quality system, with clearly defined responsibilities and described procedures and a described method of risk management referring to relevant activities.
Legal basis
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A business entity must ensure that medicinal products subject to placement have marketing authorisations or exceptional temporary marketing authorisations.
Legal basis
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Open section: Close section: Business cooperation only with suitable providers of medicinal products
A business entity must verify and cooperate only with providers of medicinal products (manufacturers, importers, wholesalers) who:
- meet the requirements of good manufacturing or distribution practice;
- operate in accordance with the regulations governing medicinal products or substances in the country of their head office, and
- those that hold manufacturing or wholesale marketing authorisations.
Legal basis
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Business entities inform the competent authority about counterfeits or suspected counterfeiting of medicinal products or substances immediately they become aware of the aforementioned.
Legal basis
Competent Authority
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Slovenčeva ulica 22
1000 Ljubljana