Which volume of the EudraLex contains the guidelines for clinical trials?
3.6. 2 Medical device If any product used in the trial requires a medical device for its administration or utilisation, refer to EudraLex Volume 10, ‘Guidance Documents Applying to Clinical Trials, Questions and Answers’.
Which EudraLex volume is are related to good manufacturing practice?
EudraLex Volume 4 Good
EudraLex Volume 4 Good manufacturing practice (GMP) Guidelines
|EudraLex Volume 4 Good manufacturing practice (GMP) Guidelines
|Quality Management (Deadline for coming into operation: 31 January 2013)
|Premise and Equipment
|Chapter 4 Documentation Revision January 2011
Is EudraLex legally binding?
It is not legally binding and, in case of doubt, reference should be made to the appropriate EU Directives and Regulations. Notice to applicants documents are publicly available under: EudraLex – Volume 2 – Pharmaceutical Legislation Notice to Applicants and regulatory guidelines medicinal products for human use.
What is auxiliary medicinal product?
Auxiliary medicinal product means a medicinal product used for the needs of a clinical trial as described in the protocol, but not as an investigational medicinal product. Examples are medicinal products used as rescue medication, challenge agents, to assess end-points in the clinical trial, or background treatment.
What is EU GMP certification?
According to EU-GMP Chapter 1, “a Pharmaceutical Quality System appropriate for the manufacture of medicinal products should ensure that (…) a state of control is established and maintained by developing and using effective monitoring and control systems for process performance and product quality.” It is important to …
What are the GMP Annex?
Annex 1 of the EU GMP guidelines describes the European Union’s requirements for the manufacture of sterile medicinal products, including those imported from non-member nations. The latest revision, to be released in 2019, is expected to have a greater reaching impact on QA/QC and all laboratory activities.
What is the difference between a regulation and a directive?
A “Regulation” is defined as a binding legislative act. It is immediately applicable in its entirety in all Member States and it overrules national laws. A “Directive” is a legislative act setting objectives that all EU countries must reach and translate into their national legislation within a defined time frame.