Foreign country packaging in Latvia
In accordance with legal acts regarding the procedure for labelling of medicinal products and requirements for package leaflets, the labelling and package leaflet of medicinal products distributed in Latvia must contain information in the state language (please, use official publication in Latvian for legal reference). In situations where the marketing authorisation holder (hereafter – MAH) is unable to ensure availability of medicinal products with labelling information and package leaflet in the state language (including repacking of medicinal product) exception can be made by distributing medicinal products in foreign packaging material.
Notification of distribution of medicinal products in foreign EU/EEA country packaging
On 1 January 2022 amendments to 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 (hereafter - Regulation No 57), came into force, determining changes in distribution of medicinal products authorised in Latvia in packaging material intended for EU/EEA countries and cases where the MAH may notify the State Agency of Medicines (hereafter – the Agency) of such distribution without requesting the permit from the Agency or repackaging the product prior the distribution.
A flowchart in which cases a notification must be submitted and in which it is necessary to obtain the Agency's permit:
In the notification following information must be included:
- name of the medicinal product;
- strength, size of the package and amount;
- batch number and expiry date;
- country for which the medicinal product was intended for sale;
- any additional information (how long the product will be distributed in foreign packaging, when product with labelling information and package leaflet in the state language will be available, for example, by repackaging the product).
We would like to point out that that the MAH is responsible for ensuring wholesalers with needed amount of package leaflet and labelling translation in state language in each consignment so that:
- The supplier of the medicinal product shall ensure the necessary number of translations of the labelling and package leaflets in the state language according to the request of the medical treatment institution, social care institution, practising veterinarians or institutions engaged in veterinary medical care;
- When product is dispensed at pharmacy to patient, pharmacist, it’s assistant or health professional could add the labelling translation and package leaflet in state language, inform the patient that the product is in foreign packaging and explain how to use the product.
Before sending the notification, please make sure that:
- The registration documentation in Latvia and EU/EEA country (in which packaging the product is intended to be distributed in) is identical;
- The period of products distribution in foreign packaging does not exceed in the Regulation 57 mentioned three months from the moment when the notification is received at the Agency and after this period availability of the product in official language will be restored (for example by repacking the product);
- medicinal products included in the Register that are also included in the list (A B or C) of reimbursable medicinal products with identical active substance, dosage and medical form are not available;
- in case if the notification to the Agency is submitted by local representative, valid power of attorney is applied to the Agency in advance or added to the notification.
To submit the notification to the Agency, please use the online form
Receiving the permit to distribute medicinal products in foreign EU/EEA country packaging
In other cases when subparagraph 6.3. or paragraph 41. of the Regulation 57 does not apply, distribution of is allowed only after receiving the permit issued by the Agency.
Please see the attached flow-chart reflecting steps that companies must take to receive the Agency’s permit for distribution of medicinal products in foreign packaging material. Please note that the flow-chart is informative in nature, and compliance with legal acts will be assessed individually in each case.
