Importance of Regulations for Advertising Medicines and Medical Devices

Healthcare regulations safeguard public health by ensuring accurate information and ethical marketing. They prevent misleading claims, promote responsible advertising, and require scientific evidence for product claims. This empowers patients with reliable information and protects them from misuse of medications. Regulations also ensure fair competition within the industry.

1. Applicable Laws for Advertising Medicines and Medical Devices in Poland

Medicines

Pharmaceutical Law of 6 September 2001
Ordinance of the Minister of Health of 21 November 2008
Act of 12 May 2011 on Reimbursement

Medical Devices

Act on Medical Devices of 7 April 2022
Ordinance of the Minister of Health of 21 April 2023

2. Additional Legislative Frameworks and Self-Regulatory Codes of Conduct

Code of Good Practice for the Pharmaceutical Industry: Developed by the Employers’ Association of Innovative Pharmaceutical Companies (INFARMA), aligned with the EFPIA Code.
Code of Ethical Business Practice: Adopted by the Polish Chamber of Commerce for Medical Devices (POLMED), implementing the MedTech Europe Code adapted to Polish law.

3. Licenses, Approvals, and Fees

There are no specific licenses, approvals, or fees required to advertise medicines or medical devices in Poland. All advertising must comply with applicable legal and self-regulatory frameworks.

4. Prescription-Only vs. Over-the-Counter Medicines

Prescription-Only Medicines: Advertising to the general public is generally prohibited, with limited exceptions for certain vaccines.
Over-the-Counter Medicines: May be advertised to the general public provided detailed regulatory requirements are met.

5. Limits on Advertising to the General Public

Medicines

General Prohibitions

Advertising must be conducted by or on behalf of the Marketing Authorization Holder (MAH)
Only authorized products may be advertised
Advertising must align with the Summary of Product Characteristics (SmPC)
Misleading, exaggerated, or unverified claims are prohibited
Advertising to children is forbidden
Use of endorsements from celebrities or healthcare professionals is prohibited

Specific Restrictions

No suggestion that medical consultation or surgery is unnecessary
No implication that health can be enhanced without medical consultation
No presentation of products as food or cosmetics
No claims of guaranteed effects or absence of side effects
No descriptions leading to self-diagnosis
No advertising of prescription-only or reimbursed medicines to the general public

Medical Devices

General Prohibitions

Advertising must be understandable by laypersons
Restricted use of healthcare professionals in advertisements
Direct appeals to children are prohibited
Only devices suitable for layperson use may be advertised publicly

Specific Restrictions

No attribution of incorrect properties or unapproved uses
No omission of risks or misleading impressions
Advertisers must retain samples of advertisements and distribution details for two years

6. Advertising to Healthcare Professionals

6.1 Medicines

Offering financial incentives, gifts, trips, or prizes is prohibited
Hospitality must not exceed the primary scientific purpose
Exceptions apply to medical/pharmaceutical items valued at no more than PLN 100 bearing promotional markings
Free samples may only be provided to authorized prescribers
Samples must be clearly marked “free sample – not for sale” and cannot include narcotics or psychotropic substances
Pharmacists may receive samples only for OTC medicines
Advertisements must include SmPC-aligned information, dispensing category, and pricing details for reimbursed products

6.2 Medical Devices

Promotional visits must be pre-arranged and occur outside working hours
Approval is required from the healthcare facility head or private practitioner
General advertising rules for medical devices apply

7. Information Required in Advertisements to Healthcare Professionals

Medicines

Product name and common name
Active ingredients and excipients
Pharmaceutical form and therapeutic indications
Dosage, administration, warnings, side effects, and contraindications
MAH details and marketing authorization
Dispensing category and pricing for reimbursed medicines

Medical Devices

Name or trade name of the device
Intended use
Identification of the advertising entity

8. Information Required in Public Advertisements

Medicines

Product name and active substances
Dosage or concentration
Pharmaceutical form and indications
MAH details
Mandatory regulatory warning notice

Medical Devices

Name or trade name
Intended use
Advertising entity identification
Manufacturer and authorized representative details
Mandatory warning notice with defined layout requirements

9. Scientific Data Requirements

Medicines

Information must be accurate, current, and verifiable
Claims must reference original and authentic scientific sources

Medical Devices

Scientific information must be understandable to laypersons
Misleading scientific references are prohibited

10. Comparative Advertising

Medicines: Public advertising may not suggest superiority or equivalence to other treatments
Medical Devices: No specific rules, but misleading comparisons are prohibited

11. Internet and Social Media Advertising

There are no specific rules for online or social media advertising. General advertising laws apply equally across all media formats.

12. Enforcement and Legal Consequences

Medicines

Main Pharmaceutical Inspector (MPI) oversees compliance
MPI may order cessation, corrections, publication of decisions, and impose fines

Medical Devices

President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products oversees compliance
Fines of up to PLN 2,000,000 may be imposed

13. Future Developments in Poland

While no specific legislative changes are currently planned, increased regulatory focus on online advertising may lead to future updates, particularly in the digital space.

How Can OMC Help?

Professional review of marketing and advertising materials with detailed reports
Support in obtaining authority approvals where required
Professional translation of marketing materials as an ISO 17100 certified agency