Other Country Topics

Austria - other studies

Laws and regulations

If the clinical trial is conducted without the use of medical devices or medicinal products there is no specific legislation in Austria. According to § 8c KaKuG (see Gesamte Rechtsvorschrift für Krankenanstalten- und Kuranstaltengesetz (Austria)/KaKuG) only an opinion from the Ethics Committee is required for a new medical method.

The Ethics Committee responsible for the physician involved must give this opinion according to the

In terms of the privacy of the participants, the following has to be regarded:

Furthermore, the clinical trial has to be conducted in accordance with the Declaration of Helsinki

 

Germany - other studies

Laws and regulations

If the clinical trial is conducted without the use of medical devices or medicinal products there is no specific legislation in Germany. Only an opinion from the Ethics Committee is required.

The Ethics Committee responsible for the physician involved must give this opinion according to section 15 of the Professional Code for Physicians (Berufsordnung).

See: German Musterberufsordnung (professional code for physicians) 

Due to the fact that Germany is a federal republic, the different state chambers of physicians (Landesärztekammern) have their own professional codes. These codes are based on the Musterberufsordnung of the German Medical Association (Bundesärztekammer) which serves as a model for the professional codes of the state chambers.

In some federal states (Bundesländer) for epidemeological studies an opinion is waived. 

In terms of the privacy of the participants the German Data Protection Act has to be regarded:

Furthermore, the clinical trial has to be conducted in accordance with the Declaration of Helsinki

 

Ireland - Other clinical research

Legislation 

If the clinical trial is conducted without the use of medical devices or medicinal products there is no specific legislation in Ireland, only an opinion from the local Ethics Committee (where the research is being conducted) is required.

There does exist, however, more general pieces of legislation which the committee must comply with, for example:

In addition, there are relevant publications from the Irish Council for Bioethics to consider (see: Irish Council for Bioethics - Guidance) and many professional organisations have guidelines, e.g.,  An Bord Altranais (Irish Nursing Board) and the Irish Medical Council.

The IMB has produced Guidelines for Pharmacogenetic Research in Ireland.

Contact

Irish Medicines Board
 

Kevin O'Malley House, Earlsfort Centre 
Earlsfort Terrace 
Dublin 2 
Ireland 
phone: +353-1-676 4971, +353-1-676 4976
fax: +353-1-676 7836

 

e-mail: imb@imb.ie

 

Poland - Other studies

Non-commercial Clinical Studies

Non-commercial clinical studies are defined in The Act on Pharmaceutical Law of 6 September 2001, Dz.U. 2008, No 45, item 271 Art. 37ia. If an owner of data from a clinical study is an academic institution or another institution with rights to issue scientific titles, researcher, patients organization, researchers organizations or another organization which aim is not gaining profits from clinical studies or manufacturing or circulating medicinal products, the study is a non-commercial clinical study. Data from a non-commercial study cannot be used for an approval of a medicinal product, for changes in current approval, nor for marketing purposes. Sponsors applying for a non-commercial study, must submit a statement that there are and will be no agreements for an approval of a medicinal product, for changes in current approval, or for marketing purposes. If there are any medicinal products obtained from a manufacturer or any other item free of expense or with reduced purchases cost, or any other type of support from them, the IEC and the President of URPL. The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) and URPL - English Information) have to be informed immediately.

Additional Links & Resources

Contact

The Ministry of Health (Poland) - Ministerstwo Zdrowia
 

ul. Miodowa 15 
00-952 Warszawa 

Poland 
phone: +48 22 634 96 00
 

 

e-mail: kancelaria@mz.gov.pl

 

Portugal - Other studies

Biobanking

In Portugal biobanks are regulated by Law (No. 12/2005) which indicates that the harvest of biological samples is allowed only when there is ethics committee approval and the collection of clinical data is regulated by the National Commission for Data Protection.

Data Protection

Clinical studies have to be in line with the Portuguese Data Protection Law (Data Protection Act – Act 67/98 of 26 October). More information (e.g., concerning homeopathic products) can be found on the website of the Instituto Nacional de Farmácia e do Medicamento (INFARMED)..

Additional Links & Resources

 

Spain - Non interventional research

Legislation 

Non interventional research is covered by: 

Non-interventional studies with authorised medicinal products are regulated by:

Additional Links & Resources

Contact

Agencia Española de Medicamentos y Productos Sanitarios/AEMPS - Spanish Medicines Agency
 

Parque Empresarial Las Mercedes Edificio 8 c/Campezo, 1 
ZIP Code: 28022 Madrid 

 
 
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