Informative Notice
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Notification of wholesaling of medicinal products in the Republic of Slovenia
An application for notification must contain:
- a cover note with a short description of the applicant;
- a valid permit for the wholesale of medicinal products;
- the reference of the wholesale of the medicinal products activity it proposes to perform in the Republic of Slovenia;
- the reference of the group of medicinal products which are the subject of wholesale in the Republic of Slovenia;
- the reference of the locations of storage sites for medicinal products;
- the reference of the distribution channel and the area of operation;
- the reference of the contact person for 24/7 availability;
- written statement from the applicant that it will ensure the collection and further treatment of waste medicinal products in accordance with the rules on the treatment of waste medicinal products.
The applicant submits the application referred to in the previous paragraph in a hard copy and in electronic form.
If the authority responsible for medicinal products establishes that the application referred to in the second paragraph is incomplete, it requests within 30 days of the receipt that the application be completed and also determines the deadline for the completion.
The deadline for issuing a certificate with which a legal entity or individual is entered in the official registry of legal entities and individuals who have obtained a permit for the wholesale of medicinal products in a Member State of the European Union and which have given notice of the activity to the authority responsible for medicinal products in the Republic of Slovenia is 90 days following the submission of a complete application.
Before issuing a certificate with which a legal entity or individual is entered in the official registry of legal entities and individuals who have obtained a permit for wholesale of medicinal products in a Member State of the European Union and who have given notice of the activity to the authority responsible for medicinal products in the Republic of Slovenia, the authority may request additional explanations or documentation from the applicant even if the application is complete, and set a deadline for the response. The period until the end of the additional deadline is not included in the 90-day deadline for issuing the certificate.