In accordance with normative acts regarding the procedure for labelling of medicinal products and requirements for package leaflets, the labelling and package leaflet of medicinal products imported in Latvia must contain information in the state language. Exceptions for distribution of medicinal products in Latvia may be made in situations where the marketing authorisation holder or wholesaler is unable to ensure availability of information in the state language. Please see the attached flow-chart reflecting steps that companies must take in order to receive Agency’s permit to distribute medicinal products in such cases.
Please note that the flow-chart is informative in nature, and compliance with normative acts will be assessed individually in each case.
On 1 January 2021, amendments to the Cabinet regulations came into force, prolonging transitional requirements (in force until 30 June 2021) for the distribution of medicinal products authorised in Latvia in packaging material intended for EU/EEA countries and packaging material intended for the market of the Baltic States.
On the distribution of medicinal products in packaging intended for the market of another State
Cabinet Regulation No 364 of 9 June 2020 and Cabinet Regulation No 741 of 10 December 2020 amended Cabinet Regulation No 57 of 17 January 2006 “Regulations Regarding Procedures for Labelling of Medicinal Products and Requirements for the Patient Information Leaflet of Medicinal Products”, prescribes the right of marketing authorisation holder to distribute medicinal products in Latvia by 31 December 2020 in packaging material intended for the market of another EU/EEA member state in which the registration dossier for this medicinal product is identical. Such a right is provided in cases where the medicinal product would otherwise be temporarily, but not longer than six months, unavailable, ori n case the producēt is indended for in hospital use.
In order for the marketing authorisation holder to take advantage of the aforementioned option and to place such medicinal products on the market, it is necessary to notify the State Agency of Medicines of the amount, batch number, expiry date, country for which the medicinal products were intended for sale and the duration of their distribution, as well as the reasons why it is not possible to repackage medicinal products.
Before sending the abovementioned notification, please make sure that:
- the medicinal products referred to in the notification in the country of origin and Latvia have identical registration documentation for medicinal products,
- in the case of a representative sending a notification to the State Agency of Medicines instead of the owner of a registration certificate.
The State Agency of Medicines shall not apply a fee for the receipt and processing of the abovementioned notification.
Placing medicines in the Baltic packaging on the market
According to Cabinet Regulation No 365 of 9 June 2020 and Cabinet Regulation No 797 of 17 december 2020, amended Cabinet Regulation No. 416 of 26 June 2007, Procedures for Distribution and Quality Control of Medicinal Products, wholesalers are allowed to distribute by 30 June 2021 medicinal products registered in Latvia in the Baltic packaging (without parallel import or parallel distribution permit), which is intended for Estonia or the Lithuania, if they are not otherwise available in Latvia, informing the marketing authorisation holder on the distribution of medicinal products.