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Romania
transparency obligations overview

Latest update: 26 September 2019 | Important Notes
PHARMACEUTICAL
MEDICAL DEVICE

Pharmaceutical Companies

Code:

What is reported:

Transfers of value related to:

  • Sponsorships/Donations/Grants
  • Contribution to event-related costs
  • Fees for Services and Consultancy
  • Research and development

Law:

What is reported:

“It is mandatory that manufacturers, MAH or their representatives to Romania as well as wholesale and retail distributors notify the NAMMD, before 31 March of the current year, all sponsoring activities as well as any other expenses undertaken the previous year, provided to healthcare professionals, patient organisations and any other type of organisations conducting healthcare activities, medical or pharmaceutical care.”

“Notification of sponsoring activities and other expenses, other than sponsoring, conducted as per paragraphs (3) and (4) shall be performed in line with the templates as provided in Annexes 1 and 2 to these Rules.”

Medical Device Companies

Law

According to the Healthcare Reform Law, medical device and pharmaceutical companies as well as their third-party representatives in Romania are required to report to the National Agency of Medicines and Medical Devices (ANMDM) all sponsorship activities and any other costs covered for HCPs, patients’ organizations and other healthcare associations.

MedTech Code

If your company is a member of MedTech Europe, disclosure should be done in line with the Disclosure Guidelines of the MedTech Europe Code of Ethical Business Practice (see part 2). The summary is provided here: link

In 2018 AFPM (Romanian Medical Products Suppliers Association) adopted the MedTech Europe Code as its Code of Ethics. AFPM is currently discussing how to implement the new Code.

The summary provided here is based on the Romanian law.

What is reported:

All sponsorship activities and any other costs covered for HCPs, patients’ organizations and other healthcare associations

Important notes:

  • This information is provided for your convenience and should not be construed as legal advice. The applicability of these requirements to your organization depends on individual circumstances. The information is not exhaustive.
  • Kindly check with your legal department and do not depend solely on the information provided here. Moreover, the rules mentioned could be subject to interpretation of local authorities/courts in the applicable jurisdiction. Lastly, be mindful of the latest update mentioned above. These rules and regulations change frequently, so it is important to determine whether the information provided reflects the most recent changes and is still applicable.
  • Reporting dates are related to the transparency obligation regarding transfers of value by pharmaceutical companies and/or medical device companies (excluding – in most cases – suppliers of in vitro diagnostics) to HCPs and HCOs. These often are based on laws or rules in codes of conduct of industry associations. In case it is based on codes of conduct, your company only needs to disclose the transfers of value on the mentioned due date if your company is a member of the association that follows that code.
  • Including a jurisdiction in the Legislative Watch does not guarantee that jurisdiction is available for reporting via the MediSpend Transparency Reporting Solution.
  • Reporting date normally means the date the transfers of value need to be published. The deadline for e.g. submission/sending the complete information to the authority could be before that date, for example to give HCPs and/or HCOs and/or the authority/association who publishes the information, the possibility to check the data the pharmaceutical companies/medical device companies are going to disclose.
  • The information does not take into consideration (unless explicitly mentioned):
    • Transparency related to clinical trials (unless it concerns transfers of value as mentioned above)
    • Transparency related to patient organizations (unless the patient organization is considered an HCO)


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