Direct Healthcare Provider Communication (DHPC)
14
OCTOBER, 2019.
A direct healthcare provider communication (DHPC) is defined as a communication intervention by which important information is delivered directly to individual healthcare professionals by a marketing authorisation holderor by a competent authority, to inform them on the need to take certain actions or adapt their practices in relation to a medicinal product.
In general, a DHPC should describe in a clear and concise way any new important information on an authorised medicinal product which has an impact on the medicine’s risk-benefit balance or conditions of use.As such, DHPC complements the so-called statutory product information, i.e. the summary of product characteristics (SPC), package leaflet (PL) and the labelling of the packaging.
The preparation and dissemination of a DHPC is described in the Guideline on good pharmacovigilance practices (GVP) Module XV – Safety communication, issuedby the European Medicines Agency (EMA), and– specifically forthe Republic of Croatia –in the national instructions for marketing authorisation holders issued by the Agency for Medicinal Products and Medical Devices (HALMED).
Overall, communicating safety information to patients and healthcare professionals is a public health responsibility and is essential to achieve the objectives of pharmacovigilance in terms of promoting the safe and rational use of medicines, preventing harm from adverse reactions and contributing to the protection of patients’ and public health.
Zorana Stanko, MA / Professional Medical Translator
14
OCTOBER, 2019.
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Office
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Marti Farm Ltd. Trade and Services
Marti Farm Ltd.
Lašćinska cesta 40, HR-10000 Zagreb
Planinska ulica 13/2, HR-10000 Zagreb
a limited liability company
Commercial Court of Zagreb
080751121
OIB
Share capital
Authorized representative
29969122438
HRK 20,000.00 (paid in its entirety)
Martina Diminić Smetiško, director of the
company (Representing the company
individually and independently, Responsible
person for data protection)
Bank account
HR3623600001102197724 (Zagrebačka banka)
HR4324020061100628669 (Erste banka)
Full company name: Marti Farm Ltd. Trade and Services
Short company name: Marti Farm Ltd.
Headquarters: Lašćinska cesta 40, HR-10000 Zagreb
Office: Planinska ulica 13/2, HR-10000 Zagreb
Legal form: a limited liability company
Court register: Commercial Court of Zagreb
Registration number: 080751121
OIB: 29969122438
Share capital: HRK 20,000.00 (paid in its entirety)
Authorized representative: Martina Diminić Smetiško, director of the company (Representing the company individually and independently, Responsible person for data protection)
Bank account: HR3623600001102197724 (Zagrebačka banka), HR4324020061100628669 (Erste banka)
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