Partners

Go to: STARS Coordination | STARS Partners | STARS Associated Partners

map of partner countriesNORWAY: Norwegian Medicines Authority (NOMA) CROATIA: Agency for Medicinal Products and Medical Devices (HALMED) ESTONIA: State Agency of Medicines (SAM) SLOVAKIA: State Institute for Drug Control (SIDC)EU: European Medicines Agency (EMA) SWEDEN: Medical Products Agency (MPA) UNITED KINGDOM: Medicines And Healthcare Products Regulatory Agency (MHRA) SPAIN: Spanish Agency of Medicines and Medical Devices (AEMPS) SPAIN: Spanish Agency of Medicines and Medical Devices (AEMPS) PORTUGAL: National Authority of Medicines and Health Products (INFARMED) POLAND: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) THE NETHERLANDS: Agency of the Dutch Medicines Evaluation Board (aCBG / MEB) MALTA: Medicines Authority (MA) LITHUANIA: State Medicines Control Agency (VVKT) LATVIA: State Agency of Medicines of Latvia (ZVA / SAMLV) ITALY: Italian Medicines Agency (AIFA) IRELAND: Health Products Regulatory Authority (HPRA) HUNGARY: The National Institute of Pharmacy and Nutrition (OGYÉI) FRANCE: French Agency for the Safety of Medicines and Health Products (ANSM) FINLAND: Finnish Medicines Agency (FIMEA) CZECH REPUBLIC: Czech State Institute for Drug Control (SÚKL) BELGIUM: Federal Agency For Medicines And Health Products (FAMHP) AUSTRIA: Austrian Agency for Health and Food Safety (AGES) GERMANY: Federal Institute for Drugs and Medical Devices (BfArM)

STARS partner countries © DLR

GERMANY: Federal Institute for Drugs and Medical Devices (BfArM)

Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte)

The BfArM is an independent federal higher authority responsible for licensing, improving the safety of medicinal products, detecting and evaluating the risks of medical devices, and monitoring the legal traffic in narcotic drugs. The most important aim of these activities is to increase the safety of medicinal products and thus that of the patients.

Coordinator of the STARS project:

  • Dr. Wiebke Löbker, pharmacist with further education in the field of medication information and head of the Innovation Office at the BfArM. She is also the BfArM´s representative at the EU-Innovation Network.

Contact details: visit website | write an e-mail | phone: +49 (0) 228 99 307 4053

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GERMANY: Paul-Ehrlich Institute (PEI )

Paul-Ehrlich Institute

The Paul-Ehrlich-Institut (PEI), the Federal Institute for Vaccines and Biomedicines, near Frankfurt/Main is a senior federal authority reporting to the Federal Ministry of Health. It is responsible for the research, assessment, and marketing authorisation of biomedicines for human use and immunological veterinary medicinal products. Its remit also includes the authorisation of clinical trials and pharmacovigilance. Other duties of the institute include official batch control, scientific advice and inspections. In-house experimental research in the field of biomedicines and life science form an indispensable basis for the manifold tasks performed at the institute. The PEI also has advisory functions nationally and internationally.

STARS contact person at PEI:

  • Bettina Ziegele

Contact details: visit website | write an e-mail | phone: +49 (0) 6103 77 4006

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GERMANY: DLR-PT

DLR Project Management Agency

DLR is a non-governmental, non-profit German research organisation. Its Project Management Agency DLR-PT is mandated by the Federal Ministry of Education and Research (BMBF) and other ministries with regard to implementation and management of governmental programmes for research funding.

The health research department of DLR-PT manages the areas of biomedical, clinical and health services research for BMBF, administrating a total of about 220 Mio € annually in several funding programmes aiming at fostering research infrastructure as well as internationally competitive research in the life science area. The health research department also hosts the National Contact Point Health Research. Regarding personalised medicine, DLR-PT is coordinating the secretariat of the International Consortium on Personalised Medicine (IC PerMed) and is an active partner in the ERA-Net cofound Personalised Medicine, both EU funded projects.

DLR-PT's department 'European and International Cooperation' includes the 'International Bureau (IB)' and the 'EU Bureau of the BMBF (EUB)', and also hosts the German EUREKA/COST Bureau. Having a strong background in R&D strategy and policy implementation with particular emphasis on international relations, IB is especially dedicated to international cooperation activities.

DLR-PT supports the BfArM and the Paul-Ehrlich Institute in the coordination of the STARS project. The contact persons are:

  • Dr. Wolfgang Ballensiefen
  • Petra Schumann

Contact details: visit website (Health department) | visit website (European and International Cooperation) | write an e-mail

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(click country to see partner profile)

AUSTRIA BELGIUM CZECH REPUBLIC EU FINLAND FRANCE
HUNGARY IRELAND ITALY LATVIA LITHUANIA MALTA
NETHERLANDS POLAND PORTUGAL SPAIN SWEDEN UNITED KINGDOM


AUSTRIA: Austrian Agency for Health and Food Safety (AGES)

BASG - Federal Office for Safety in Health Care

The Austrian Agency for Health and Food Safety is an expert organisation striving to minimise risks in areas of public health, animal health, food safety, medical and drug safety as well as consumer protection. Founded in 2002, the agency is fully owned by the Republic of Austria.
One of its divisions, the Austrian Medicines and Medical Devices Agency (AGES MEA), is responsible for issuing new marketing authorisations for medicinal products in Austria and for the surveillance of already markteted medicinal products and medical devices in terms of effectivity and possible side effects, also inspecting manufacture, transport and storage. AGES MEA also monitors blood- and tissue-vigilance issues.
AGES MEA is closely linked to BASG, the Federal Office for Safety in Health Care (BASG), providing BASG with necessary resources, staff and infrastructure. When carrying out sovereign activities, the employees of AGES MEA are acting on behalf of BASG.

Contact details: visit website | write an e-mail | phone: +43 (0) 50 555-36111

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BELGIUM: Federal Agency For Medicines And Health Products (FAMHP)

FAMHP is the Belgian authority responsible for the quality, safety and efficacy of medicines and health products. It works at both national and international level to ensure the population the optimal use of the medicines and health products they need.

Contact details: visit website

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CZECH REPUBLIC: Czech State Institute for Drug Control (SÚKL)

SÚKL is a government institution of the Czech Republic. It is responsible for the regulation of the production of pharmaceuticals and the clinical evaluation of medicines. It also monitors the marketing of both medicines and medical devices.

Contact details: visit website

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EU: European Medicines Agency (EMA)

The European Medicines Agency is a decentralised agency of the European Union responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.

Contact details: visit website

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FINLAND: Finnish Medicines Agency (FIMEA)

Finnish Medicines Agenvy Fimea

The Finnish Medicines Agency FIMEA is the national competent authority with a mission to promote the health and safety of the population through regulatory activities. Fimea is responsible for enforcement and inspections in the pharmaceuticals sector, regulating medicinal, blood and tissue products, and the evaluation of pharmacotherapies. Besides the society, we serve global customers and businesses ranging from academic groups to SMEs and large companies. We are also actively engaged in the European medicines regulatory network. Fimea’s STARS project team consists of two persons: Head of Section Pirjo Inki, and Research Coordinator Marko Kallio.

Contact details: visit website | write an e-mail  | phone: +358 (0) 29 522 3341

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FRANCE: French Agency for the Safety of Medicines and Health Products (ANSM)

The French Agency for the Safety of Medicines and Health Products is responsible for assessing the benefits and risks associated with the use of health products throughout their life-cycle. It assesses the safety, efficacy and quality of these products and balances patient safety with access to novel therapies.

Contact details: visit website

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HUNGARY: The National Institute of Pharmacy and Nutrition (OGYÉI)

National Institute of Pharmacy and Nutrition (OGYÉI)

The National Institute of Pharmacy and Nutrition is a licensing authority for pharmaceutical and public administrational matters. It provides the Hungarian public with safe, effective and quality medicines in accordance with the regulations.

Contact details:  visit website |
write an e-mail: Tivadar Szabó (General coordinator) / Katalin Szénási (Representative of Division of Project Coordination)

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IRELAND: Health Products Regulatory Authority (HPRA)

Health Products Regulatory Authority

The Health Products Regulatory Authority regulates medicines, medical devices and other health products in Ireland. Supporting innovation is a key strategic focus for the organisation. The HPRA has scientific and clinical expertise in all of the areas that it regulates. The HPRA’s Innovation Office provides regulatory guidance and advice to any individuals or groups (including academic researchers and small or medium enterprises who are developing innovative health products or technologies.

Contact details: visit website | write an e-mail | phone: +353 1 6764971

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ITALY: Italian Medicines Agency (AIFA)

Italian Medicines Agency (AIFA)

The Italian Medicines Agency is the national authority responsible for drugs regulation in Italy. It is a public body operating autonomously, transparently and according to cost-effectiveness criteria, under the direction of the Ministry of Health and under the vigilance of the Ministry of Health and the Ministry of Economy. It cooperates with the regional authorities, the National Institute of Health, research institutes, patients’ associations, health professionals, scientific associations the pharmaceutical Industry and distributors.

Contact details: visit website

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LATVIA: State Agency of Medicines of Latvia (ZVA / SAMLV)

State Agency of Medicines of Latvia

The State Agency of Medicines of Latvia (SAMLV) is a State institution under the supervision of the Ministry of Health of the Republic of Latvia. SAMLV was established in 1996. Its operational objective is to implement local and international pharmaceutical legislation in order to ensure that the products (medicines, medical devices, blood, cells, tissues and organs) used in health care, as well as the involved companies and their activities comply with certain requirements. The agency provides objective and analytical information for the purposes of state administration, to the public, health care specialists, cooperation partners, as well as international and EU institutions.

Contact details: visit website | write an e-mail (Jānis Zvejnieks, Deputy Director of the State Agency of Medicines) | phone: +37 167078431

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LITHUANIA: State Medicines Control Agency (VVKT)

State Medicines Control Agency

The State Medicines Control Agency is a governmental body of the Republic of Lithuania. Its main responsibility is the protection of public health, through the evaluation and supervision of medicines for human use.

Contact details: visit website | write an email |
phone: +370 5 263 92 64

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MALTA: Medicines Authority (MA)

The Medicines Authority protects and enhances public health in Malta through the regulation of medicinal products and pharmaceutical activities.

Contact details: visit website

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THE NETHERLANDS: Agency of the Dutch Medicines Evaluation Board (aCBG / MEB)

The Dutch Medicines Evaluation Board assesses and monitors the efficacy, risks and quality of medicines for humans and animals. The Board is an independent administrative body supported by a specialised agency.

Contact details: visit website

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POLAND: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL)

Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

URPL is a central government administrative authority competent for matters concerning the marketing authorisation of medicinal and biocidal products, medical devices and clinical trials.

Contact details: visit website | write an e-mail: Magdalena Pajewska-Lewandowska / Dr. Ewa Bałkowiec-Iskra

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PORTUGAL: National Authority of Medicines and Health Products (INFARMED)

INFARMED is a Portugese government agency accountable to the Health Ministry, that evaluates, authorises, regulates and controls human medicines as well as health products, medical devices and cosmetics.

Contact details: visit website

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SPAIN: Spanish Agency of Medicines and Medical Devices(AEMPS)

Spanish Agency for Medicines and Medical Devices (AEMPS)

The Spanish Agency of Medicines and Medical Devices is the Spanish health authority providing guarantees on the quality, safety, efficacy and correct information of medicines along their whole life cycle. The AEMPS has launched the Spanish office for support of innovation and knowledge on medicinal products to integrate, coordinate and strengthen different activities supporting research, innovation and access to medicinal products. More than 700 people form the staff of the AEMPS; most of them highly qualified professionals with expertise in any area of regulatory sciences.

Contact details: visit website | write an e-mail

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SWEDEN: Medical Products Agency (MPA)

The Medical Products Agency is Sweden's national authority responsible for regulation and surveillance of the development, manufacturing and marketing of drugs and other medicinal products.

Contact details: visit website

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UNITED KINGDOM: Medicines And Healthcare Products Regulatory Agency (MHRA)

The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. It is an executive agency, sponsored by the Department of Health and Social Care.

Contact details: visit website

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CROATIA: Agency for Medicinal Products and Medical Devices (HALMED)

The Agency for Medicinal Products and Medical Devices is a legal entity vested with public authority. The Agency was established by the Republic of Croatia and is supervised by the Ministry of Health. HALMED provides services pertaining to medicinal products, medical devices, homeopathic medicinal products and veterinary medicinal products.

Contact details: visit website

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ESTONIA: State Agency of Medicines (SAM)

The State Agency of Medicines (SAM) is a governmental body with the aim to
ensure that medicines approved for use in Estonia for the prevention, treatment and diagnosis of human and animal diseases are proven to be efficacious, of high quality and safe. Currently the SAM is an agency under the Ministry of Social Affairs.

Contact details: visit website

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NORWAY: Norwegian Medicines Authority (NOMA)

The Mission of The Norwegian Medicines Agency (Statens legemiddelverk, NOMA) is to evolve and safeguard public and animal health by ensuring the efficacy, quality and safety of medicines and to administer and enforce the medical devices regulation.

Contact details: visit website

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SLOVAKIA: State Institute for Drug Control (SIDC)

The mission of SIDC to control the quality, efficacy and safety of medicinal products and medical devices, to issue the decisions of the registration of human medicines and to issue licences for activities with specified substances, to perform the state supervision in the field of pharmacy, to execute state administration in the matters of drug antecedents, to control the manufacture and wholesale distribution of medicinal products and medical devices, as well as to cooperate with EU organisations.

Contact details: visit website

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