LOCAL REGULATORY AFFAIRS SERVICES IN FINLAND, THE BALTICS AND THE EU
Managing country-specific regulatory requirements can be challenging for Marketing Authorisation Holders (MAHs). Success depends on having the right local knowledge to ensure compliance and streamline processes.
Medfiles offers dedicated local regulatory affairs services in Finland and the Baltic countries through our in-house experts. Our in-house team combines in-depth regulatory knowledge with a comprehensive understanding of country-specific requirements and regulations.
For projects outside the countries covered by our in-house teams, we provide seamless support through our trusted network of qualified partners. This ensures consistent quality, clear communication, and full accountability. We only involve partners when our own experts are actively leading or contributing to the project, so clients benefit directly from our expertise while gaining access to local knowledge and capabilities.
Medfiles’ regulatory affairs services in figures
30+
YEARS OF EXPERIENCE – services from 1990
40+
REGULATORY EXPERTS WITH AVG. 11 YEARS OF eXPERIENCE
75+
CLIENTS IN 18 COUNTRIES
(EU, ROW)
300+
PROMOTIONAL MATERIAL REVIEWS / YEAR
Read about our local regulatory affairs services:
PHARMACEUTICAL PRODUCT INFORMATION AND TRANSLATION SERVICES
Our Product Information Team consists of translators and regulatory experts who have years of experience in tasks related to product information texts: summaries of product characteristics (SmPC), package leaflets (PIL) and labelling. Our competent team delivers easy to read, compliant texts tailored to the target audience, even within strict schedules. In the translation process, we utilise computer-assisted translation tools and translation memory tools to ensure the consistency of style and terminology. Regulatory review is included in our process, and we employ the four-eyes principle to guarantee the highest possible quality.
Our services include:
- preparation of product information text
- translations of product information texts
- in Finnish, Swedish, English, Estonian, Latvian and Lithuanian
- other languages through our partner network
- package leaflet user tests and bridging reports
- proofreading of mock-ups
- preparation and updating of abbreviated SmPCs
- updating national medicines compendia.
See also:
- Outsourcing local regulatory affairs: 4 examples of tailored support in the Nordics and Baltics
- Bimeda & Medfiles: Partnership in veterinary regulatory affairs in the EU
- Vetcare & Medfiles: Working together on the maintenance of marketing authorisations of vet medicines
- How to implement common Baltic packs for human medicines
- Cooperating with Baltic medicines authorities in regulatory submissions: Practical experiences from Estonia, Latvia and Lithuania
REVIEW OF MARKETING MATERIALS FOR MEDICINAL PRODUCTS
Ensuring that your marketing materials meet local regulatory and ethical standards is essential—especially when balancing compliance with effective messaging. Our experienced team will make sure that your materials comply with the applicable local regulations and marketing regulations based on the classification of your product (Rx/OTC). Our service includes medical, editorial and ethical review. After our review process, you can be sure that the medical facts, language, claims and references in your marketing materials are in accordance with the local legislation and ethical codes, without losing the marketing edge.
Our experts have extensive experience in various types of marketing materials and working with businesses of all sizes, from small pharmaceutical companies to large-scale multinational enterprises. We have local expertise in the Nordic and the Baltic countries, and our team reviews materials according to the local requirements. We give clear feedback for your materials and evaluate the potential risks while offering practical solutions to address them.
We will be happy to review the following materials for you:
- Over-the-counter drug brochures, social media content, websites and promotional videos
- Prescription drug brochures and other materials
- Business PowerPoint presentations and other presentation materials
- Company invitation letters
We also offer tailor-made training on the subject.
See also:
- Outsourcing local regulatory affairs: 4 examples of tailored support in the Nordics and Baltics
- Pharmaceutical marketing in Finland – Q&A on requirements and compliance
- Pharma marketing compliance in the Nordics
- Promotional material compliance in the Baltics
- Vetcare & Medfiles: Working together on the maintenance of marketing authorisations of vet medicines
GOOD DISTRIBUTION PRACTICE (GDP), RESPONSIBLE PHARMACIST AND PRODUCT COMPLAINTS
Medfiles offers responsible pharmacist services for medicinal product wholesalers in Finland, ensuring compliance with Good Distribution Practice (GDP) requirements. Our qualified professionals hold relevant degrees in pharmacy, have completed GDP training, and bring extensive knowledge of the pharmaceutical industry. We offer full responsible pharmacist services or tailor-made solutions according to your needs – depending on whether you need a full-time solution or a short-term back-up, for example during holidays. In addition to acting as responsible pharmacists, our team can assist with product complaint handling and other GDP-related tasks.
Our service package is fully customisable to meet the specific needs of your company, offering peace of mind and regulatory confidence.
Responsible pharmacists in Finland
- Full-time designated person
- Deputy responsible pharmacist
- Delegated tasks
GDP services
- Wholesale dealer’s authorisation application
- Preparation and update of standard operating instructions (SOP)
- GDP audits
- GDP training and consultancy
- Consulting services
- import and logistics
- narcotics control and mandatory reserve supplies
- Handling product complaints
- Shortage reporting
See also:
REGULATORY INTELLIGENCE MONITORING
For an MAH it may be difficult to keep up with the ever-changing array of regulations, legislature and local practises. Medfiles has a system in place for monitoring these issues on a local level (Finland, Baltics, Nordics) as well as on EU level. We follow regularly the newsfeed concerning local authorities, relevant legal fields and other specific stakeholders. On EU level, we are constantly monitoring CMDh, CMDv, EMA and HMA for any minor or major news.
Followed topics include e.g.
- National procedures
- National fees
- Sunset Clause
- OTC Switch (Changes of Legal Status)
- Packaging and Labeling Requirements
- Pricing and Reimbursement
- Products requiring Marketing Authorizations.
We can set up a Regulatory Intelligence monitoring on a regular basis, including service that is tailor-made for your particular needs.
LOCAL DATABASES
As a part of local Marketing Authorisation maintenance, we can update the local databases. This service can be done on behalf of the MAH, marketer/distributor or local affiliate, on whose behalf Medfiles would have access to the databases.
Local databases in Finland and the Nordics include services such as e.g. Pharmaca Fennica, FASS, Felleskatalogen and applying the Nordic Article Number (Vnr). Also requesting of product codes and price updates are a part of our services.
Medfiles as LEO Pharma’s responsible pharmacist in Finland
In Finland, every company with a medicinal product wholesale dealer’s licence must appoint a responsible pharmacist. For foreign companies, this requirement brings two main challenges: language and local qualification. That’s why LEO Pharma relies on Medfiles’ expert to serve in this role in Finland.
“The role of the responsible pharmacist is a critical position, especially due to the language barrier. Not many of LEO Pharma’s Nordic colleagues understand and speak Finnish, which makes Medfiles’ support invaluable. – – I am very happy with the support and knowledge that Medfiles provides. The quality of their work always meets our expectations.”
– Kristien Vanelderen, Head of Quality International, LEO Pharma
Medfiles and LINK Medical: partners in regulatory and pharmacovigilance services in Northern Europe
Medfiles and LINK Medical have partnered for nearly 20 years to offer clients a seamless solution across eight Nordic and Baltic countries through a single point of contact. This collaboration provides clients with a strategic advantage, offering them efficient access to local expertise and harmonised processes across the region.
Contact us
You may also be interested in:
- Outsourcing local regulatory affairs: 4 examples of tailored support in the Nordics and Baltics
- Selected non-prescription medicines to be sold outside pharmacies in Finland
- Cooperating with Baltic medicines authorities in regulatory submissions: Practical experiences from Estonia, Latvia and Lithuania
- What regulatory lifecycle activities must MAH manage after approval?
- Planning a marketing authorisation transfer in the Baltic countries: key considerations
- How to implement common Baltic packs for human medicines
- Medfiles as LEO Pharma’s responsible pharmacist in Finland
- Pharmaceutical marketing in Finland – Q&A on requirements and compliance
- Pharma marketing compliance in the Nordics
- Promotional material compliance in the Baltics
- Medfiles and LINK Medical: partners in regulatory and pharmacovigilance services in Northern Europe
- Meet our people: Variations and other MA maintenance tasks across the EU
- Meet our people: New marketing authorisations and lifecycle management for human medicines
- Bimeda & Medfiles: Partnership in veterinary regulatory affairs in the EU
- Vetcare & Medfiles: Working together on the maintenance of marketing authorisations and pharmacovigilance of veterinary medicines