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Romania
hcp engagement rules

Latest update: 3 February 2021 | Important Notes

Pharmaceutical Companies

Authority

ARPIM: “The Romanian Association of International Medicine Manufacturers was founded in 1995, with a view to facilitating Romanian patients’ access to the best and latest pharmaceutical research and development. We are the association that supports the common objectives of the most important 29 international innovative medicine manufacturers operating in Romania. They represent together 70% of the pharmaceutical industry business in Romania.”

Medical Device Companies

Authority

AFPM: “AFPM aims to be the representative and unitary voice of the Romanian medical industry, in the direction of ensuring a healthy competitive market, with free access to information and competition.”

http://www.afpm.ro/

Resources

ARPIM Ethics Code: “The ARPIM Code on the Promotion of Prescription–only Medicines to, and Interaction with, Healthcare Professionals (hereafter “ARPIM Code”) shall represent a reference that should thus assist in judging if promotional practices related to medicinal Medicines are in alignment with acceptable ethical standards.”

https://arpim.ro/

https://arpim.ro/codul-de-etica/

Resources

AFPM Code not found. According to a secondary resource: “On 14 February 2018 AFPM adopted the MedTech Europe Code as its Code of Ethics (“AFPM Code”) (Cod de Conduită şi Etică în Afacer). AFPM is currently discussing how to implement the new Code.” (see: https://hivda.hu/wp-content/uploads/2018/11/ComplianceHandbook_2018_FINAL_20181010.pdf

AFPM website: http://www.afpm.ro/

Important Notes and Disclaimer:

  • 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 solely depend 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.
  • Including a jurisdiction in the Legislative Watch does not guarantee that jurisdiction is available for reporting via the MediSpend Transparency Reporting Solution.
  • Transparency Reporting: 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.
  • Transparency Reporting: 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.
  • Transparency Reporting: The information does not take into consideration (unless explicitly mentioned):
    • Transparency reporting related to clinical trials (unless it concerns transfers of value as mentioned above)
    • Transparency reporting related to patient organizations (unless the patient organization is considered an HCO)
  • HCP Engagement: This page provides links to useful information for life science companies who are interacting with healthcare professionals (HCPs) and healthcare organizations (HCOs).
  • HCP Engagement: The rules mentioned are only applicable to members of the mentioned industry/trade association.
  • HCP Engagement: We selected links to codes of conduct of industry/trade association that are leading/much followed in the respective jurisdiction and contain (in most jurisdictions), compared to e.g. the law, more detailed guidance on compliant interactions with HCPs and HCOs.
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