Product Information, Labelling & Promotional Compliance
We review, author, certify, and maintain everything that communicates about your medicinal product after approval: the SmPC and product information, the packaging and labelling, the patient leaflet, the promotional materials, the digital content, and the scientific information provided to healthcare professionals and the public. We operate the Drug Information Officer function, run the promotional review process, manage artwork compliance, and handle the authority and industry code interactions when questions arise. For companies that need this built from scratch, we design the governance system, the SOPs, and the review workflows. For companies that already have systems in place, we operate them, audit them, or fix them.
Examples of How We Support
These are just examples to illustrate the kind of work we do day to day. The fastest way is usually a short call to understand your situation and discuss how we can help.
Launch PI package
You are launching a product in the EU and need the full product information package prepared and certified: SmPC aligned with the approved labelling, patient information leaflet tested for readability, and packaging artwork that passes QRD template checks, national blue box requirements, braille specifications, and serialisation placement rules. You need this coordinated across multiple languages and markets, with annotated and clean versions ready for each national authority.
Promotional material certification
Your marketing team has prepared promotional materials for an upcoming congress, social media campaign and a new detail aid for field representatives, but nobody in-house has the regulatory and scientific expertise to certify them. You need an expert who can assess every claim against the SmPC, ensuring it is accurate, current, and fully substantiated. Claims, comparisons, and references must be carefully reviewed. Prescribing information needs to be verified that it is complete, legible, used appropriately and correctly presented. Ultimately, you need a reviewer who can interpret and apply the regulations, challenge where needed, and provide clear, defensible rationale for approval decisions to ensure materials are fully compliant, and able to withstand external scrutiny before sign-off, without compromising your marketing intent.
DIO coverage
You have marketed products across multiple EU member states and your Drug Information Officer function is either unfilled or stretched. You need a named Informationsbeauftragter (or equivalent) who actually reviews scientific and medical information, ensures SmPC consistency across all communications, and handles medical information requests from healthcare professionals.
Safety variation cascade
A safety variation has changed the SmPC, and now the labelling, PIL, promotional materials, and HCP-facing information all need updating across every market where the product is sold. You need coordinated implementation: updated artwork, annotated and clean texts for regulatory submission, national implementation tracking, and confirmation that all materials reflect the new wording within the required timelines.
Promotional review process
Your promotional review process exists on paper but has never been tested in a complaint or inspection. SOPs are outdated, the certification workflow is unclear, training records are incomplete, and you have no systematic way to track what has been approved, when, and by whom. You need someone to rebuild the system so it works in practice, not just on paper.
New market promotional material compliance
You are entering a new EU market and need to understand what the local advertising code requires, how the national DIO/scientific service obligation works, and whether your existing promotional materials can be adapted or need to be rebuilt from scratch.
Understanding Product Information, Labelling & Promotional Compliance
Product information, labelling, and promotional compliance are distinct disciplines that share a common root: the approved SmPC. Every document that communicates about a medicinal product, whether to a patient, a healthcare professional, or the public, must be traceable to the SmPC and defensible under the applicable regulatory and industry code framework.
This page covers three connected areas:
Product information and labelling: the development, review, and lifecycle maintenance of SmPC text, patient information leaflets (PILs), and packaging artwork. This includes QRD template compliance, readability testing, serialisation and safety features, braille, and multilingual packaging management.
Promotional and medical communications compliance: the review, certification, and governance of promotional materials, non-promotional materials, disease awareness content, digital communications, and scientific information provided to healthcare professionals and the public.
Drug Information Officer (DIO) / Informationsbeauftragter services: the operational function that ensures all scientific and medical information about a product is accurate, balanced, consistent with the SmPC, and compliant with applicable legislation. This is a legal obligation in Germany (AMG Section 74a) and has equivalents across EU member states.
For the appointment of named compliance roles (DIO, QPPV, Stufenplanbeauftragter) as legal representation services, see Legal Representation. For variation-driven SmPC and labelling updates as part of post-approval regulatory operations, see Post-Approval & Lifecycle Management. For the medical and scientific writing that supports clinical and regulatory documents, see Medical & Scientific Writing.
What We Do
Our Workstreams
We structure product information, labelling, and promotional compliance work into defined workstreams so responsibilities and interfaces are clear.
Product information authoring
SmPC, PIL, and labelling text authoring and maintenance per QRD & maintenance templates. National blue box content management. SmPC/PIL/labelling consistency verification. Support for QRD template version transitions (e.g., current v10.4 to v11 when adopted). Coordination of product information updates across EU languages via regulanet partners.
Artwork development & compliance
Mock-up development and review. QRD template adherence verification. Safety-critical content checks. Technical specification review (barcodes, serialisation per FMD 2011/62/EU, unique identifiers, tamper-evident features). Braille compliance. Country-specific artwork adaptation. Print-readiness review.
Readability & patient-facing materials
Readability testing (user consultation) design and execution. User comprehension assessment. Risk minimisation element integration in leaflets and packaging. Formatting and layout review for patient guidance and error reduction.
Promotional review & certification
Medical-legal-regulatory (MLR) review of promotional materials for HCPs and the public. SmPC alignment verification. MedDRA-compliant adverse event classification in materials. Claim substantiation assessment. Digital content review (websites, social media, e-detailing, email). Disease awareness and non-promotional material categorisation. Pre-launch material compliance review.
Drug Information Officer services
Named DIO/Informationsbeauftragter in Germany and across EU member states via regulanet. Scientific and medical information review. Medical information enquiry handling. SmPC consistency oversight across all information channels. Coordination with marketing, medical affairs, and regulatory teams.
Governance, monitoring & audit
SOP development for promotional review and approval workflows. Certification process design. Compliance monitoring frameworks. Audit trail documentation. Periodic review schedules. Code complaint response support. Promotional system auditing. Trend analysis and benchmarking against regulatory expectations.
Labelling lifecycle management
Variation-driven artwork updates (Type IA, IB, II). Safety update implementation (DHPC-linked changes, risk minimisation revisions). Annotated and clean version preparation for regulatory submissions. National implementation tracking. Multi-market coordination. Serialisation and FMD element updates.
Where This Fits in the Development Journey
Product information, labelling, and promotional compliance become relevant as a product approaches approval and continue throughout its marketed life.
Discovery & Concept
Not typically applicable. Early TPP work may inform future labelling and promotional positioning, but active product information and promotional compliance work begins later.
Clinical
Investigator's Brochure content and clinical trial material compliance (not promotional, but disease awareness and recruitment materials may require review in certain jurisdictions).
Regulatory Submission & Approval
SmPC, PIL, and labelling text finalised as part of Module 1 during MAA/NDA preparation. Mock-ups and specimens prepared for regulatory review. Readability testing conducted. Pre-launch material preparation begins within pre-approval promotion constraints.
Launch & Market Access
Full promotional material development, review, and certification for launch. DIO function activated. Artwork and packaging finalised for commercial production. Multi-market labelling coordination. Launch training materials reviewed for compliance.
Post-Market & Lifecycle Management
Ongoing labelling lifecycle management. Variation-driven updates. Safety-related product information changes. Promotional material maintenance and periodic re-review. DIO/Informationsbeauftragter ongoing function. Promotional auditing and governance. Code complaint management.
Sample Deliverables
The scope depends on whether the engagement covers product information, promotional compliance, DIO services, or a combination. These are typical outputs.
Complete SmPC, PIL, and labelling text package in QRD format, ready for regulatory submission, with annotated versions showing changes from previous approved text. 
Artwork compliance report for outer carton, immediate packaging, blister text, and patient leaflet, documenting QRD adherence, safety-critical content verification, serialisation placement, and braille check results. 
Readability testing report (user consultation) for a patient information leaflet, including study design, participant demographics, comprehension results, and recommended revisions. 
Certified promotional material package: reviewed detail aid, congress materials, and digital assets with documented certification trail, claim-by-claim SmPC cross-reference, and supporting evidence log. 
Promotional governance framework: complete SOP set covering review workflow, certification responsibilities, documentation requirements, training programme, and compliance monitoring schedule. 
DIO operational report: quarterly summary of medical information enquiries handled, scientific review activities completed, and SmPC consistency checks performed. 
Labelling implementation tracker: multi-country status document showing artwork update progress, regulatory submission status, and national implementation deadlines for a safety-driven labelling change. 
Code complaint response package: structured response addressing complaint allegations, supported by evidence documentation and compliance trail. Example Projects
Illustrative Example
Mid-size EU pharma company, marketed OTC portfolio
The company had launched products across 12 EU markets but had no centralised labelling management system. Artwork versions varied between markets, several PILs were based on outdated SmPC versions, and braille compliance had never been formally verified. Regenold conducted a full artwork audit across the portfolio, identified 47 discrepancies, and implemented a structured remediation programme with country-by-country implementation tracking. All packaging was brought into compliance within 6 months without supply disruption.
Illustrative Example
Biotech company entering EU market, first product launch
A US-based biotech preparing its first EU launch had no promotional review infrastructure, no DIO function, and no governance framework for EU advertising code compliance. Regenold built the complete promotional governance system (SOPs, certification workflow, training programme), appointed DIO/Informationsbeauftragter across 5 launch markets via regulanet, and reviewed all launch materials. The company passed its first EFPIA member association code audit without findings within 12 months of launch.
Illustrative Example
Generic pharma company, safety-driven labelling update across 20 markets
Following a PSUR-triggered SmPC safety update, the company needed coordinated labelling changes across 20 EU member states within the regulatory implementation deadlines. Regenold managed the annotated and clean text preparation, country-specific artwork adaptations, national submission tracking, and implementation confirmation. All markets were updated within the required timelines.
Product Type Considerations
Product information, labelling, and promotional compliance requirements vary by product type. The regulatory framework, the applicable advertising codes, the product information format, and the DIO obligations depend on what you are bringing to market.
Prescription medicines (Rx)
Full ABPI/EFPIA code compliance required for promotional materials. Prescribing information must accompany all promotional content. SmPC, PIL, and labelling must follow QRD templates. DIO/Informationsbeauftragter obligation applies. Promotional materials may only be directed at persons qualified to prescribe or supply. Disease awareness materials must not cross into product promotion. Digital content requires HCP verification mechanisms in most jurisdictions.
Generics and biosimilars
Product information must align with the reference product SmPC unless justified divergence is approved. Promotional claims must be carefully framed to reflect the approved indications and not imply therapeutic superiority without supporting data. Multi-market labelling coordination is often the primary challenge: managing artwork across many SKUs, languages, and national requirements simultaneously, particularly during initial launch across EU member states.
Food supplements and cosmetics
Governed by separate regulatory frameworks (Regulation (EC) No 1924/2006 for nutrition and health claims, Regulation (EC) No 1223/2009 for cosmetics). Product information requirements, claims rules, and advertising restrictions differ fundamentally from medicinal products. Delivered through NutraCompliance, our dedicated food and cosmetics team. See the NutraCompliance website for specialist support.
OTC and consumer health products
Advertising to the general public is permitted but governed by separate codes (e.g., PAGB in the UK, national OTC advertising rules in EU member states). Pack design and labelling must support safe self-selection, including clear dosing instructions, prominent warnings, and patient-friendly language. Rx-to-OTC switches require a complete promotional framework transition at the point of reclassification. Readability testing is particularly critical given the self-care context.
Medical devices and IVDs
Device labelling follows MDR/IVDR requirements (UDI, IFU, Declaration of Conformity references), not the pharmaceutical QRD framework. Promotional activities for devices are governed by national advertising law and MDR Article 7 (claims and CE marking references), not Directive 2001/83/EC. The DIO obligation does not apply to devices, but equivalent scientific information responsibilities exist under MDR. For combination products, labelling must satisfy both pharmaceutical and device requirements in a single package. Device labelling is covered in detail on the Medical Device Regulatory Services page.
Launching a product and need compliant labelling, promotional review, or a DIO in place?
Tell us what you need and we'll outline how we can help. Whether it's a single artwork review or a full promotional compliance programme, we start with a short call to understand your situation.
Contact usFrequently Asked Questions (FAQ)
What regulatory frameworks govern promotional materials for medicinal products in the EU?
Promotional activities fall under Directive 2001/83/EC, Title VIII (Articles 86-100), which defines advertising broadly as any activity designed to promote the prescription, supply, sale, or consumption of medicinal products. Because this is a directive rather than a regulation, EU member states transpose its provisions into national law with varying interpretation and enforcement. In practice, promotional compliance is largely governed and enforced through national industry codes that implement the EFPIA Code of Practice. Each country has its own code body, complaint mechanism, and enforcement approach.
How does promotional compliance differ from country to country within the EU?
The EU framework sets minimum standards, but national implementation creates significant divergence. Some countries require pre-approval of promotional materials by the competent authority (France, for example, requires ANSM visa for HCP-facing advertising). Others rely primarily on industry self-regulation with post-hoc complaint-based enforcement. Hospitality thresholds, disclosure requirements, digital advertising rules, and the scope of what constitutes "promotion" versus "information" all vary. We navigate these differences through direct expertise in major EU markets and through regulanet partners for country-specific requirements.
What is the difference between the DIO/Informationsbeauftragter and a medical affairs function?
The DIO is a legal obligation, not an organisational choice. In Germany, AMG Section 74a requires every MAH to designate an Informationsbeauftragter responsible for ensuring that all scientific and medical information about the company's medicinal products is accurate and consistent with the approved SmPC. The role covers oversight of all product-related communications, including promotional materials, medical information responses, and scientific content. Medical affairs is a broader organisational function. The DIO may sit within medical affairs, but the legal responsibility is specific and cannot be delegated informally. We provide the named DIO function on an outsourced basis, with people who understand both the legal obligation and the practical day-to-day work.
When is readability testing required for patient information leaflets?
User consultation (readability testing) is a regulatory requirement for all new marketing authorisation applications in the EU. The applicant must demonstrate that the patient information leaflet is comprehensible to the target patient population. For post-approval changes, additional testing may not be required for certain variations if adequate justification can be provided. In practice, significant changes to the leaflet's structure, layout, or safety-critical content often warrant re-testing. We advise on when testing is needed and manage the process end to end.
What elements of packaging require compliance verification before printing?
Every component of packaging must be verified against the approved SmPC and applicable regulatory requirements: outer carton, immediate packaging (blister foils, bottle labels, vial labels), patient information leaflet, and any inserts. Verification covers QRD template adherence (section ordering, headings, standard wording), safety-critical accuracy (product name, strength, pharmaceutical form, route of administration, warnings, contraindications), serialisation elements (2D barcode, unique identifier, product code per FMD Delegated Regulation 2016/161), braille (product name and strength on outer packaging), and national-specific blue box content. A single error in any of these elements can trigger a regulatory observation, a reprint, or in serious cases a recall.
How are safety-driven labelling changes coordinated across multiple EU markets?
When a safety update changes the SmPC (for example, following a PSUR assessment, signal detection finding, or authority-initiated referral), the updated product information must be implemented across all markets where the product is authorised, within the timelines set by the relevant procedure. We prepare the annotated and clean texts, adapt artwork for each market (accounting for language, national requirements, and pack-size variations), coordinate submissions with national competent authorities, track implementation status country by country, and confirm that all printed materials in circulation reflect the updated wording within the required deadlines.
Can digital promotional content be used across EU markets, or does it need country-specific adaptation?
Digital content raises specific compliance challenges. A promotional website accessible from multiple EU countries must comply with the advertising rules of each country where it is visible. Some jurisdictions restrict access to HCP-only content behind verification mechanisms; others have specific rules about social media engagement, email opt-in requirements, or the inclusion of mandatory information in digital formats. The EFPIA/IFPMA Joint Digital Guidelines provide a framework, but national codes add layers of specificity. We review digital content for cross-border compliance and advise on access controls, audience segmentation, and country-specific adaptations needed before deployment.
How does the EU pharmaceutical legislation revision affect promotional compliance?
The European Commission's proposals to revise Directive 2001/83/EC include modifications to the advertising provisions. The European Parliament adopted amendments in April 2024, and the Council established its position in June 2025. The proposals refine the definition of advertising, introduce new provisions on comparative advertising, and update the framework for digital communications. A transitional period of three years is expected after adoption, meaning the new rules would enter force around 2028 or 2029. We monitor these developments and advise clients on preparing their promotional governance systems for the transition.