MARKETING AUTHORISATION MAINTENANCE SERVICES
Once a medicinal product has received marketing authorisation (MA), it is approved for commercial use. In order to maintain the marketing authorisation and ensure that your product remains compliant and available on the market, you must continue to fulfill your maintenance obligations. Variations to the original marketing authorisation, such as changes to manufacturing processes, formulations, or packaging materials, often require additional regulatory approval to ensure ongoing compliance and product safety.
Our experienced Marketing Authorisation team provides comprehensive marketing authorisation lifecycle maintenance services for your medicinal products, regardless of the active substance. Depending on your needs, you can outsource the full maintenance of your product – or just specific parts – to us. Our experienced team, with diverse scientific backgrounds, specialises in the lifecycle management of marketing authorisations across Europe with special local expertise in Nordics and Baltics. While our regulatory team is specialised in the EU market, we are actively growing our FDA expertise and are seeking partnerships for post-approval lifecycle support, such as labelling updates, annual reports, CMC variations/post-approval changes and Compilation support for eCTD documents.
marketing authorisation maintenance services in the EU
- variation applications, notifications and renewal applications required by the authorities
- regulatory strategies
- switches from prescription drug to over-the-counter drug status (Rx/OTC)
- marketing authorisation transfers to new marketing authorisation holders.
marketing authorisation maintenance services in the USA
- support for market expansion to the US
- documentation (supplemental applications).
Read more about our marketing authorisation maintenance services:
Variation applications, notifications and renewal applications
After approval, medicines live through many changes – updates to CMC, labelling, and packaging, or new sites and suppliers. We take care of the whole process; we review your proposed change, confirm or propose the correct variation classification, and agree on the most efficient submission route – whether that’s a single variation, a grouped application, or a worksharing procedure.
Operationally, we handle eCTD publishing and electronic submissions via CESP/EMA gateways, manage timelines, track commitments, and respond to authority questions through approval and implementation. Whether you need strategic guidance, extra capacity, or fully outsourced maintenance for a large portfolio, we provide pragmatic, hands-on support that streamlines workloads, reduces risk and cost, and frees your teams to focus on your priorities. Our goal is simple: to implement your changes smoothly, keep your products compliant in the market, and save you time and cost without cutting corners.
Regulatory strategies
Our aim in regulatory strategy is to plan and execute smooth marketing authorisation maintenance according to your needs. Maintaining marketing authorisation for pharmaceutical products requires a strategic, proactive regulatory approach throughout the product lifecycle. Medfiles offers a holistic approach for regulatory maintenance, assisting you in handling of e.g. large variation packages (changes in manufacturing sites etc.), multi-country packages and coordinating Product Information or administrative updates concerning several products. We can take a global regulatory role and keep your EU and ROW (Rest of the world) affiliates and other stakeholders well informed of any changes, take care of timetables and be the point of contact for competent authorities. Global regulatory strategy requires local regulatory intelligence, which can only be achieved with the long-standing and diverse experience in the regulatory field that Medfiles has.
Switches from prescription drug to over-the-counter drug status (Rx/OTC)
Over-the-counter (OTC) availability allows consumers to obtain medications without visiting a healthcare provider, increasing convenience and reducing delays in treatment. Switching a drug from prescription (Rx) to OTC status offers significant strategic, commercial, and operational benefits for the marketing authorisation holder. The benefits include e.g. market expansion, increased sales and brand recognition. The decision to apply OTC status is always made by the marketing authorisation holder, not the authority. Successfully implemented Rx to OTC switches require a holistic view of the process and good coordination skills, for which our experts at Medfiles have received appraisal from clients.
Marketing authorisation transfers to new marketing authorisation holders
Marketing authorisation transfers are common in the pharmaceutical industry and can be driven by several strategic, operational, and regulatory reasons, such as mergers and acquisitions, strategic business decisions and market expansion. They help companies to expand their product portfolios, enter new markets or consolidate operations. Transfers must be carefully timed to avoid supply disruptions and ensure all post-authorisation obligations are met. Regulatory authorities require that marketing authorisation transfers follow specific procedures, which can have local differences. Transfer process consists of planning, regulatory assessment, document preparation, submission process, post-approval activities as well as pharmacovigilance and quality-related actions.
In addition to the services above, our experts can serve as part-time or full-time insourced resource when you face sudden resource challenges. Our insourcing service allows you to fix your staff shortage or get a replacement to fill in for longer absences.
FAQ: Why outsource EU post-market activities?
Post-market regulatory activities in the EU include, for example, variations, renewals, updates to Product Information and labelling, monitoring and reporting of adverse reactions, and risk management. Managing these activities in a timely manner and in accordance with the latest EU regulatory requirements ensures the continued availability of your products on the market.
Why outsource instead of keeping all maintenance task in-house?
By outsourcing more routine, yet critical regulatory maintenance activities, you can enjoy agile regulatory expertise without the management overhead of maintaining internal teams. Rather than being overwhelmed with routine tasks, your team can focus on generating greater value and increasing the business’s competitive advantage.
How often are these maintenance activities needed?
Practically all the time. Renewals must be completed at set intervals, safety data may require urgent updates, and regulatory guidelines frequently change. Outsourcing ensures that no obligation is overlooked or delayed.
Can I outsource only part of the maintenance activities?
Absolutely. You can choose to outsource specific tasks e.g. preparing a variation application, maintenance tasks of a specific product or the entire portfolio management. This way, you get exactly the level of support you need – cost-effectively and flexibly.
How does outsourcing maintenance activities reduce risks?
An experienced partner continuously monitors regulatory changes and acts proactively. This protects you from delays, penalties, or even withdrawal from the market. The result is a more stable business foundation allowing you to focus on your core competencies.
Does outsourcing mean losing control?
Not at all. You retain decision-making power at all times – your partner acts as an executor and advisor. This combination gives you a clearer overview and frees time for strategic leadership.
What is the benefit of having a partner with EU-wide and local expertise?
EU regulatory compliance involves both centralised and member-state level requirements. Local expertise ensures that language versions, authority communication, and national specifics are handled smoothly – without delays or misunderstandings.
How does technology benefit me when outsourcing?
You gain access to advanced systems (e.g. eCTD and electronic tracking tools) without heavy in-house investments. This saves costs, improves transparency, and keeps you aligned with regulators’ own digital transformation.
Why Medfiles?
With over 35 years’ experience of European regulatory processes, our team combines deep legislative knowledge, scientific backgrounds, and hands-on authority interaction. We help you secure compliance, manage your entire portfolio efficiently, and free up your resources to focus on growth and innovation. When you outsource EU post-market regulatory activities to Medfiles, you get a secure and cost-efficient solution that keeps your products on the market and your team focused where they create the most value.
Global pharma company & Medfiles: Cooperation in obtaining and maintaining marketing authorisations in the EU
“Medfiles has been a valuable partner for us during the registration and maintenance of products in Europe. They consistently provide prompt and accurate responses whenever there are inquiries or concerns related to European approvals.”
This is how a client from outside the EU, who has been working with Medfiles for 7 years, describes the partnership. The company initiated cooperation with Medfiles when they required assistance in entering the European market. The cooperation has involved applying for new marketing authorisations as well as managing products post-approval.
Other services closely related to marketing authorisation maintenance:
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
ELECTRONIC SUBMISSION SERVICES (ECTD)
Preparing electronic common technical documents (eCTDs) for submission requires both the right tools and technical expertise. For many small and mid-sized pharmaceutical companies, investing in eCTD publishing software may not be cost-effective—especially when submission volumes are low.In such cases, it may be wise to save resources and outsource your eCTD publishing tasks. Medfiles uses an eCTD publishing tool that is widely used by various authorities around the world. With over 10 years of experience in eCTD publishing, we are a reliable and competent partner for all your eCTD publication activities.
We compile electronic applications in accordance with existing regulations and guidelines. In case of eCTD or VNeeS, we always use the current version of the appropriate validation tool to ensure that the compiled sequence is technically valid, and send it to the authorities using the designated channels, such as CESP or EMA Gateway.
Our team is experienced with all eSubmission formats and can consult other medical or pharmaceutical experts, ensuring the high quality of our eSubmission services. A second expert review is always included in our eSubmission price.
Our services include:
- compilation of eCTD and VNeeS sequences and other types of electronic applications
- submission of applications via the CESP portal, EMA Gateway, Eudralink, FDA ESG or secure email.
See also:
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. Using computer-assisted translation and translation memory tools, we ensure consistency in terminology and style across all documents. 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.
By partnering with us, you gain more than just translation – you gain a trusted team committed to delivering product information that supports both regulatory approval and patient understanding.
See also:
insights on marketing authorisation maintenance
Our expert team regularly writes blogs on human regulatory affairs, covering topics such as marketing authorisation maintenance and local regulatory affairs.
Medfiles’ regulatory affairs services in figures
30+
YEARS OF EXPERIENCE – services from 1990
40+
REGULATORY EXPERTS WITH AVG. 11 YEARS OF eXPERIENCE
1600+
written variations / renewals
300+
PROMOTIONAL MATERIAL REVIEWS / YEAR
450+
eSUBMISSIONS / YEAR
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