The Regulation on the Promotion of Medicinal Products for Human Use and Foods for Special Medical Purposes entered into force on 1 January 2025, with certain provisions applying from 1 July 2025. Rather than a clause-by-clause summary, this article examines how companies should rebuild their compliance programmes, which processes have genuinely changed, and what the new sanctions architecture means in practice. This is not a cosmetic update: in scope, in notification duties and in its sanctions architecture, the regulation re-frames how promotion operates.
Historical background: from Law No. 1262 to the new regulation
Promotion of medicinal products in Türkiye rests fundamentally on Law No. 1262 on Pharmaceuticals and Medical Preparations (1928), the umbrella statute that subjects everything from licensing to promotion to state authorisation and supervision. Over the decades, the Law's promotion-related powers were concretised through regulations and communiqués; scientific meetings, free sample distribution and promotional materials were long governed by these sub-legislative instruments.
The new regulation consolidates this tradition under a single roof while introducing three significant changes. First, foods for special medical purposes are brought under the same promotional discipline as medicinal products, closing the grey zone around products used like medicines but classified as foods. Second, patient support programmes enter explicitly, for the first time, the scope of a legislative text. Third, pre-distribution notification of materials to the Agency becomes a process that can be run end-to-end in a single digital flow.
Expanded scope: patient support programmes are now inside promotion law
The regulation's most strategic change is the direct inclusion of patient support programmes. Over the past decade these programmes — patient education, adherence support, administration training, nursing services, digital tracking platforms — were mostly governed by corporate policies and industry codes. Under the new regulation they are assessed within the promotion framework, with specific notification and compliance obligations.
The practical meaning operates on three levels. First, programme design must be tested against the principles of promotion law rather than a default of "non-promotional service": does the programme carry communication beyond the approved indication? Is product promotion directed at non-healthcare professionals? Do programme materials fall within e-notification? Second, the company or vendor running the programme must structure its record-keeping and reporting duties for the new architecture. Third, where programmes process patient data, KVKK/GDPR compliance and promotion-law compliance must be managed together at the same table — because violations of the two regimes can compound within a single programme.
Who may promote: qualifications for product managers and medical liaisons
The regulation sets qualification requirements for personnel conducting promotion. Promotion staff must hold degrees in pharmacy, medicine, dentistry or the other healthcare professions defined in the regulation, with additional provisions for graduates of doctoral pharmacology programmes and for candidates covered by transitional clauses. For foods for special medical purposes, dietetics qualifications are also recognised.
For companies this has two consequences. First, workforce and training planning must be tied to the regulatory calendar: job descriptions for staff not meeting qualification requirements should be re-scoped, while qualifying staff should be documented in an internal registry. Second, responsibility in outsourced models is clarified: since ultimate responsibility remains with the marketing authorisation holder even when promotion runs through agencies, agency staff qualifications and training become part of vendor management.
Core principles: what stays the same and what is clarified
- Licence requirement: promotion may concern only licensed or authorised products. Products under application, awaiting import authorisation, or refused cannot be promoted.
- Target audience: promotion is directed only at healthcare professionals. Public-facing promotion of prescription products — including through digital channels — is prohibited.
- Advertising prohibition: all activities outside the promotion defined in the regulation count as advertising. This broad definition means every piece of content marketing, social media management and patient-education activity must pass the "promotion or advertising?" test.
- SmPC/PIL channel restriction: Agency-approved SmPC, PIL and approved-use information may be published only in Agency-defined channels and on the company's own official website; use outside these channels, including in digital information resources, must follow Agency guidelines.
- Scientific accuracy: promotional content must be consistent with the approved SmPC, supported by scientific literature, and free of misleading language.
Scientific meetings and satellite symposia
Congress sponsorships remain the busiest arena of promotion. Scientific meetings and product promotion meetings follow the procedures set by the Agency's Application Guideline: meeting notifications are submitted through the electronic application system with programme and speaker information; satellite symposia attach to the parent congress's notification process. Independence must be preserved in sponsorship, speaker selection and content; speaker remuneration, accommodation and travel support should be documented according to corporate policies alongside industry codes.
The most commonly missed point in practice: every material distributed during a congress, every visual used at a booth and every piece of content published on digital platforms may fall within e-notification. The meeting calendar and the material approval calendar must be merged into one master calendar.
Free samples: limited, labelled, recorded
The regulation confines sample distribution tightly. Samples may be distributed only within the approved indication, for promotion purposes, and in limited quantities. Each sample must be of minimum pack size and labelled "promotional sample — not for sale". Products containing narcotic or psychotropic substances may not be sampled at all. Distributions must be recorded and reported annually to the Agency.
The operational translation has three layers: field-team capture at the moment of distribution (to whom, how much, on what justification), regional reconciliation, and the central reporting layer feeding the annual declaration. The annual obligation forces sample data into a standard data model year-round; firms that attempt to compile spreadsheets at year-end lose time and generate error risk.
Material notification: e-submission before distribution
The most concrete procedural novelty is the requirement to submit promotional materials to the Agency's electronic system before the distribution date. This changes the three-ring chain of material approval: internal legal review → medical review → e-notification. Every link must be version-controlled; every combination of text, visual and target channel must be tracked as a separate record.
Successful e-notification operations share three traits: the material demand calendar opens at least a quarter before the marketing calendar; service-level targets are agreed jointly with legal and medical for approve-reject cycles; and the annual material inventory lives in a single source of truth. These three practices turn notification from a bottleneck into routine workflow.
Digital promotion: the digital counterpart of channel restrictions
The regulation explicitly covers digital information resources. SmPC/PIL content may be used outside Agency-defined channels only in line with guidelines; but visibility of prescription products on out-of-audience platforms, influencer collaborations, and marketing use of patient stories all risk being assessed as advertising. In social media management, the boundary between "disease awareness content" and "product promotion content" must be bound to joint legal-medical approval.
The second arena digital transformation has created is remote detailing and hybrid meetings. Materials for these channels are subject to the same e-notification and approval processes; meeting recordings and participant lists should be retained as evidence that may be requested in inspection scenarios.
The sanctions architecture: a three-step system and chain effects
Where a violation is detected, the Agency first issues a warning to the marketing authorisation holder. On repetition after the warning, promotion of the product may be suspended for up to three months. A further violation within one year following a three-month suspension leads to a promotion ban of up to one year.
The cost of a product-level ban exceeds the ban period itself: a three-month suspension during launch can permanently alter prescribing habits; disease-awareness programmes and congress sponsorships tied to the product also come under stop risk. This is why sanctions-risk management should be reported to the board as the top-level indicator of the compliance programme.
How to build the compliance programme: a five-layer model
- Policies and procedures: a promotion policy, material approval SOP, sample distribution procedure, patient support programme guideline and social media policy held in one version-controlled document family.
- Roles and approval matrix: for each material type, the sequence and authority limits across marketing, medical, legal and regulatory affairs.
- Training and certification: annual regulatory training for field and office staff; onboarding modules for new hires; contract-bound training requirements for agency personnel.
- Record and reporting infrastructure: e-notification records, sample distribution logs, meeting notifications and year-end reports consolidated in a single data model.
- Internal audit and corrective action: periodic field audits, material inventory verification, and root-cause analysis of deviations through incident management processes.
Compliance checklist: the first 90 days
- Inventory all active promotional materials; verify their e-notification status.
- Map your patient support programmes against the regulation's scope; isolate components requiring notification.
- Collect qualification documents of promotion staff; link gaps to a training plan.
- Re-model sample distribution records to the annual reporting format.
- Run a joint legal-medical scan of digital channels for advertising-risk content.
- Enter your scientific meeting calendar, with guideline deadlines, into the master calendar.
- Define a crisis management team and communication plan for sanction scenarios.
Industry codes and their relationship with the regulation
The regulation is the base of the compliance architecture; yet the most-referenced texts in daily practice are industry codes of ethics. The codes of international company associations and sector bodies define behavioural rules on gifts, accommodation, speaker fees, consultancy payments and relationships with healthcare professionals in more detail than the law. A well-built programme separates the two layers explicitly and runs their procedures separately but interlocked: a legal violation produces administrative sanctions, a code violation produces membership and reputational sanctions. Keeping "legally compliant" and "code-compliant" as separate checkboxes on internal approval forms teaches teams the difference.
The practical value of this dual structure shows in case management: an act may be legally possible yet problematic under the code (a meeting in a luxurious venue), or the code may be silent where the regulation prescribes sanction (un-notified digital content). Compliance must maintain both text sets and run a gap analysis at least annually.
Common mistakes: lessons from inspection findings
- Unapproved material leakage: old-version brochures distributed "due to equipment failure" at a congress stand — the classic proof of how version control is bypassed in the field. Even physical copies should carry a single inventory number.
- Statements beyond the SmPC: phrases like "promising in a broader patient group" count as communication circumventing the approved indication; medical approval must test wording against the indication map.
- Wrong audience: mixing patient education with product promotion in projects with patient associations. Disease-awareness content must separate product names and brand links with clear lines.
- Sample-record inconsistency: annual-declaration mismatches between field and central records; mandatory digital capture at the moment of distribution solves this at the root.
- Missed meeting-notification deadlines: the congress calendar feeding late into the marketing calendar; guideline deadlines must be entered backwards into the master calendar.
- Social-media sharing chains: even "likes" and "re-shares" by corporate accounts may count as promotion; the approval layer must cover these acts.
Measuring the programme: the KPI set
Unmeasured compliance stays rhetoric. Indicators recommended for board reporting: material approval time (target: x business days including e-notification), e-notification coverage (share of distributed material notified; target 100%), sample-record consistency (centre-field reconciliation deviation), training coverage of staff (annual, target 100%), internal-audit findings and closure time, incident count and root-cause distribution, Agency correspondence and warnings. The trend of these indicators is the leading indicator of sanctions risk: managing the finding curve before a warning arrives is the programme's purpose.
Roles and authority: who approves what?
The material approval matrix should be built on four signature lines: Marketing (ownership of need and content), Medical affairs (scientific accuracy and SmPC compliance), Legal (legal and code compliance), Regulatory affairs (e-notification and Agency records). Lines may shorten by material type (medical weight grows in disease-awareness content); but no material reaches the field on a single signature. An escalation path must be defined for disputes, with decisions recorded with rationale. The matrix is also a governance exhibit for external auditors and Agency inspectors.
Design principles for patient support programmes
Patient support programmes are the new scope's most question-generating area; good design begins by distinguishing three purposes: patient education (general information on disease and treatment), adherence support (supporting use as prescribed) and product promotion (communication to HCPs within the approved indication). Programme components should be classified under these purpose labels; each component's audience (patient, caregiver, HCP/SMM — Satış Mesul Müdürü, the responsible sales manager defined in Turkish promotion legislation) and channel defined explicitly. Components aimed at patients and caregivers may carry no product name, image or brand link; content stays limited to the disease and general treatment processes. Components aimed at HCPs — under the Turkish Promotion Regulation, physicians, dentists and SMMs (Satış Mesul Müdürleri) — are subject to every rule of promotion law (approval, e-notification, SmPC compliance).
The data layer must satisfy three regimes at once: KVKK/GDPR (explicit consent, purpose limitation, secure transfer), promotion law (notification and records) and corporate confidentiality. The common trait of failed programmes is going to the field without building these three layers into a single data model. Build the triangle — programme ownership in medical affairs, operations at the vendor, oversight in compliance — and fix the programme's annual audit calendar in writing.
The training programme: building a compliance culture
Sustainability of compliance depends on the team internalising the rules. An effective training architecture has three layers: the onboarding module (everyone new, within 30 days; core concepts and reporting channels), the annual refresher (all promotion-facing staff; current regulation and code changes through case studies), and role-based deepening (sample and meeting scenarios for the field; content approval for digital teams; SmPC compliance for medical). Trainings should close with exams and certification, records kept per person. The strongest learning tool is the real case review: narrating the company's own (or anonymised sector) incidents with their decision chains outlasts rule text. The maturity indicator of compliance culture is staff self-reporting deviations — which requires corrective, not punitive, incident management.
Frequently asked questions: queries from practice
- When must a congress brochure be e-notified? Before distribution; once the congress calendar is fixed, the application-approval-notification chain should start.
- Do satellite-symposium slides count as material? Yes; every promotional content, speaker slides included, is subject to approval and notification processes.
- May I use the disease name on an awareness page? The disease name may be used; product names, imagery and indication references cross the promotion boundary.
- Is sharing a scientific paper on social media promotion? The sharing format (comment, visual, targeting) can confer promotional character; every share must pass the approval process.
- May the list of physicians I sampled be shared outside the Agency? No; records exist for Agency reporting and inspection and may not be used commercially.
- Must old-version materials be destroyed? When a new version takes effect, old stock must be withdrawn from the field with destruction records kept.
- Do nurse visits in a patient support programme count as promotion? Education and adherence visits run under the approved protocol are not promotion, provided content and record rules are observed.
- Who reports a violation, and where? Internal reporting lines and Agency channels must be defined separately; the reporter must be protected.
Sources and key takeaways
Core sources: the Regulation on the Promotion of Medicinal Products and Foods for Special Medical Purposes (in force 01.01.2025 / 01.07.2025) with its application guidelines; Law No. 1262; TİTCK announcements and industry ethics codes. Recommended monitoring: the Official Gazette and TİTCK legislation pages (amendments), association bulletins (practice examples), and law-firm regulatory briefings (interpretation differences). Our key takeaways: (1) treat the regulation not as periodic burden but as continuous governance; (2) patient support programmes and digital channels are the two new compliance fronts; (3) e-notification must run as a single versioned flow; (4) sanctions are product-level and chain-reacting — sanctions-risk belongs on the board agenda; (5) only measured compliance is defensible: without a KPI set the programme stays rhetoric.
Conclusion
The new regulation moves promotion into an institutional compliance discipline. As important as the rules themselves is their proceduralisation: from material approval to sample records, from patient support programmes to digital content, every flow must be measurable, auditable and repeatable. Omega Arastirma supports companies at the intersection of promotion law and market access strategy — process design, policy documentation, team training and regulatory monitoring. Reach us via the service application form and request a rapid gap analysis of your current promotion processes against the regulation.