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.
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.
Before distributing medicinal products in Latvia in packaging materials intended for EU/EEA countries in which the registration documentation is identical the MAH shall notify the Agency in following cases:
- Medicinal products are supplied for use to a medical treatment institution, social care institution, practising veterinarians or institutions engaged in veterinary medical care (according to subparagraph 6.2. of Regulation 57);
- Other medicinal products that are going to be distributed in foreign packaging no longer than three months from the moment when the notification in the Agency is received (in accordance with subparagraphs 6.2. and 6.3. of the Regulation 57):
o such medicinal products included in the Medicinal Product Register of Latvia (hereafter – the Register) that are also included in the list (A B or C) of reimbursable medicinal products 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;
o such medicinal products included in the Register that are authorised via centralised authorisation procedure if other medicinal products included in the Register with identical active substance, dosage and medical form are not available.
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).
In addition, amendment to Regulation No 57 that came into force on 1 January 2022 prolonged until 31 December 2022 transitional requirements for the distribution of medicinal products authorised in Latvia in packaging material intended for EU/EEA countries in which the registration documentation is identical and otherwise medicinal products shortly, but no longer than six months would not be available (paragraph 41 of the Regulation 57).
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 (or six months according to paragraph 41 of the Regulation 57) 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.
In other cases when subparagraph 6.3. or paragraph 41. of the Regulation 57 does not apply, distribution of medicinal products in foreign packaging 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.