This form is intended for marketing authorisation holders (or their local representatives) to notify the Agency about the beginning of distribution of medicinal products intended for the market of another EU/EEA country in the Republic of Latvia in accordance with Subparagraph 6.1 of the Regulation No 57 of the Cabinet of Ministers of the Republic of Latvia "Regulations Regarding Procedures for the Labelling of Medicinal Products and the Requirements to Be Set for Package Leaflets of Medicinal Products" (adopted on 17 January 2006) without requesting the permit from the Agency or repackaging the product prior the distribution.
In accordance with Subparagraph 6.3. of Regulation No 57, medicinal products mentioned in the subparagraph can be distributed to wholesalers in foreign packaging no longer than three months from the moment when the notification in the Agency is received.
Contact information will only be used in cases where additional information from the applicant is needed.
Required fields are marked with an asterix (*).
Statement of the State Agency of Medicines regarding processing of personal data
In accordance with Subparagraph 184.108.40.206., medicinal products included in the list (A B or C) of reimbursable medicinal products can be distributed only if other medicinal products also included in the list (A, B or C) of reimbursable medicinal products with identical active substance, dosage and medical form are not available.