Message 001
Communication from the Commission - TRIS/(2026) 1210
Directive (EU) 2015/1535
Notification: 2026/0218/FI
Notification of a draft text from a Member State
Notification – Notification – Notifzierung – Нотификация – Oznámení – Notifikation – Γνωστοποίηση – Notificación – Teavitamine – Ilmoitus – Obavijest – Bejelentés – Notifica – Pranešimas – Paziņojums – Notifika – Kennisgeving – Zawiadomienie – Notificação – Notificare – Oznámenie – Obvestilo – Anmälan – Fógra a thabhairt
Does not open the delays - N'ouvre pas de délai - Kein Fristbeginn - Не се предвижда период на прекъсване - Nezahajuje prodlení - Fristerne indledes ikke - Καμμία έναρξη προθεσμίας - No abre el plazo - Viivituste perioodi ei avata - Määräaika ei ala tästä - Ne otvara razdoblje kašnjenja - Nem nyitja meg a késéseket - Non fa decorrere la mora - Atidėjimai nepradedami - Atlikšanas laikposms nesākas - Ma jiftaħx il-perijodi ta’ dewmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Nu deschide perioadele de stagnare - Nezačína oneskorenia - Ne uvaja zamud - Inleder ingen frist - Ní osclaíonn sé na moilleanna
MSG: 20261210.EN
1. MSG 001 IND 2026 0218 FI EN 28-04-2026 FI NOTIF
2. Finland
3A. Työ- ja elinkeinoministeriö
Työllisyys ja toimivat markkinat -osasto
PL 32
FI-00023 VALTIONEUVOSTO
Puhelin +358 (0)295 16001
Faksi +358 1606 2160
maaraykset.tekniset.tem@gov.fi
3B. Sosiaali- ja terveysministeriö
Turvallisuus- ja terveysosasto
PL 33
FI-00023 VALTIONEUVOSTO
Puhelin +358 (0)295 16001
Faksi +358 2951 63415
kirjaamo.stm@gov.fi
4. 2026/0218/FI - C10P - Pharmaceuticals
5. Draft government proposal to Parliament for legislation on the development of pharmacy operations
6. Medicinal products
7.
Requirements which reserve access to particular providers
The proposal would amend to the system for the authorisation of pharmacy operations, which would contribute to the functioning of the nationwide pharmacy network. The aim is to reform the regulation of branch pharmacies to better reflect actual regional needs and to expedite the addition of a conditional branch pharmacy to be included in a pharmacy licence when the availability of medicinal products in the region so requires. The proposal would exempt pharmacy pick-up lockers from location-based regulation. Pick-up lockers must continue to be suitable for the proper and safe storage of medicines.
The proposal would allow online sales for holders of retail marketing authorisations for non-prescription medicinal products. As a condition to commence operations, the notification procedure would apply to all operators. The proposal would streamline remote pharmacy services by improving the regulation of online pharmacy services and the conditions for the provision of such services. The amendments would allow for flexible cooperation between pharmacies for the supply of the medicinal product. As a condition to commence operations, the notification procedure would apply equally to all operators. The proposal would strengthen the conditions for price competition in the pharmaceutical sector by allowing online pharmacies to set prices that differ from those of brick-and-mortar pharmacies through amendments to the Medicines Act and the Medicines Pricing Regulation. The more flexible approach to the pricing of online pharmacies would be open to all pharmacies that provide online services.
Amendments to the Medicines Act are proposed to identify mechanical dispensing as a separate activity from pharmacy operations. The regulation would be based on the nature of the operation and the specific characteristics of the supply of medicinal products. The licence for mechanical dispensaries and the associated range requirements would apply equally to all operators engaged in medical dispensation. The range requirements are based on patient safety and ensuring continuity of medical care and do not discriminate between operators based on their background or business model.
The proposed measures are necessary to achieve public health objectives.
Some of the proposed measures are of a deregulatory nature (pick-up locker and price regulation schemes). Other measures are based on the specific nature of pharmaceutical services and the need to ensure patient safety, including the safeguarding of regulatory oversight (changes to the licensing system, enabling cooperation between pharmacies regarding the supply of medicines and the retail licences of online service operators for non-prescription medicines, and the operating licence for automatic dispensaries).
These changes are necessary to improve the availability and efficiency of the pharmaceutical supply. Furthermore, the proposed regulations would modernise the regulatory framework and improve access to medicines and the flexibility of the system. Allowing greater flexibility for online pharmacies to price their products is necessary to ensure that price regulation does not unduly restrict competition in electronic distribution channels and to give pharmacies a genuine opportunity to develop their online services.
The proposed notification and authorisation procedures are based on safeguarding public health. Product range requirements in the pharmaceutical dispensary licence are necessary to ensure that the operator providing the dispensing service has access to a range of medicines that guarantees appropriate and continuous patient care and meets medical needs.
The proposed measures are proportionate to the achievable public interest objectives. Regulations have been mainly streamlined. The level of regulation has been considered to be necessary for the realisation of safety and the needs of regulatory oversight. Special patient safety risks associated with the operation impact the level of regulation.
The regulation on pick-up lockers waives location restrictions, but requirements for appropriate storage, transport and the liability of the licensed pharmacist are retained. In this way, the regulation achieves its aim through the least possible interference in the provision of services. The relaxation of price regulation and the removal of the equal price requirement for non-prescription medicines in the pharmacy’s online service and brick-and-mortar shop will also increase flexibility, but will not change the basis for pricing in other respects.
A notification procedure would apply to the online service of the holder of a retail licence for a range of non-prescription medicinal products and to the pharmacy’s cooperation arrangements for the delivery of the medicinal product. A licence is required to operate a pharmacy. The notification procedure, which is a prerequisite for launching an online pharmacy and commencing cooperation, is a less burdensome and less restrictive means of ensuring that the supervisory authority has access to information and the ability to carry out supervision.
The separate licence for mechanical dispensaries would apply to operators whose activities involve specific pharmacovigilance risks. Regarding the composition of the range of medicinal products, only general principles would be laid down. The dispensary unit could determine its own range of medicinal products, as well as the approaches to range management, as is the case under the current regulatory framework. When determining the range of medicinal products to be stocked in a dispensary unit, consideration should be given to national clinical practice guidelines and cost-effectiveness from the perspectives of both society and the patient.
Taken as a whole, the proposed measures do not go beyond what is necessary to achieve the pursued objectives and represent the least intrusive form of regulation. Therefore, they fulfil the proportionality requirement under Article 15 of the Services Directive.
Directive (EC) N° 2006/123 on services in the internal market
8. The proposal would also change the licensing system for pharmacy operations in a way that would promote the functionality of the nationwide pharmacy network and ensure the social sustainability of its maintenance. It is proposed that, in order to ensure the availability of medicines in the area, a public notice procedure be introduced for the establishment of a branch pharmacy, which is a condition of the pharmacy licence under the pharmacy licensing system, and that the licence holder be given the opportunity to apply to convert a branch pharmacy for which they are already authorised into a branch pharmacy that is a condition of the licence. The proposal would exempt pharmacy pick-up lockers from location-based regulation.
The proposal would allow online sales for holders of retail marketing authorisations for non-prescription medicinal products (official notification procedure). In addition, the provision of online pharmacy services will be streamlined by developing the regulatory framework and conditions for the provision of such services. The amendments allow for more flexible cooperation, including between pharmacies, in the supply of medicinal products. Commencing operations would require submitting a notification to the supervisory authority. The proposal would strengthen the conditions for price competition in the pharmaceutical sector by allowing online pharmacies to set prices that differ from those of brick-and-mortar pharmacies through amendments to the Medicines Act and the Medicines Pricing Regulation.
In addition, amendments to the Medicines Act are proposed to identify mechanical dispensing as a separate activity from pharmacy operations (authorisation procedure), which would clarify both the position of dispensary operators and the customer base as part of the pharmacotherapy process and regulatory supervision.
The proposal is based on the provisions of Prime Minister Petteri Orpo’s government programme concerning a safe and effective pharmaceutical supply system and pharmacy network. The proposed amendments to the Medicines Act are due to enter into force on 1 January 2027.
9. The purpose of the amendment to the provisions on branch pharmacies would be to streamline the pharmacy licensing procedure and to enable the maintenance of a nationwide pharmacy network. In particular, the changes would apply to branch pharmacies that are a condition of a pharmacy licence and essential for the availability of pharmacy services in the region. Pharmacies are subject to location-based regulations, which, under the current Medicines Act, have also covered the area served by a pharmacy’s pick-up locker. The aim of the bill would be to extend the area in which pharmacy pick-up lockers may be located beyond the pharmacy’s immediate vicinity, which is particularly important for the delivery of prescription medicines when patients use the pharmacy’s online service. In addition, it is proposed that pharmacies be allowed to set different prices for non-prescription medicinal products across their various service channels.
The Medicines Act (395/1987) and the Medicines Decree (693/1987) define a limited range of non-prescription medicinal products, comprising groups of medicines assessed as low-risk, considered suitable for safe self-medication without the need for medical advice. The limited range of non-prescription medicinal products refers to medicinal products that have been granted an extension of the sales channel referred to in Section 23e(2) of the Medicinal Products Act and whose sale outside a pharmacy requires a retail licence for non-prescription medicinal products issued by a public authority. The purpose of the proposed amendment and section 54j of the Medicines Act would be to enable holders of a retail licence for non-prescription medicinal products to also organise the remote sale of medicinal products.
The operation of a mechanical dispensary would require a licence. Provisions on dispensing activities would be laid down in sections 12b to 12i of the Medicines Act. The Medicines Act would, among other things, lay down general principles governing the composition of the range of medicines stocked by a dose-dispensing unit. The dispensary unit could determine its own range of medicinal products, as well as the approaches to range management, as is the case under the current regulatory framework. When determining the range of medicinal products to be stocked in a dispensary unit, consideration should be given to national clinical practice guidelines and cost-effectiveness from the perspectives of both society and the patient. National treatment practices should be considered in selecting the range, thus supporting the fulfilment of the therapeutic needs of the user of the medicinal product.
10. Basic text references: The basic texts have been provided in connection with an earlier notification:
2021/0371/FIN
11. No
12.
13. No
14. No
15. Yes
16.
TBT aspects: No
SPS aspects: No
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European Commission
Contact point Directive (EU) 2015/1535
email: grow-dir2015-1535-central@ec.europa.eu
