IMPs: How do GDP Guidelines apply?

Is distribution of Investigational Medicinal Products covered by the new Guidelines on Good Distribution Practice (GDP)? What needs to be considered can be found here.

http://www.gmp-compliance.org/enews_4424_IMPs%3A%20%20How%20do%20GDP%20Guidelines%20apply%3F_8397,8527,9008,Z-PDM_n.html

GMP News: IMPs: How do GDP Guidelines apply?

The 2013 Guidelines on Good Distribution Practice (2013/C 343/01) apply to medicinal products for human use. Investigational Medicinal Products (IMPs) are also medicinal products for human use. But is IMP distribution really covered by the new Guidelines? The Guidelines focus on wholesale distribution of medicinal products. And IMPs are normally not distributed via wholesalers. However IMPs are not particularly excluded. The Guideline may therefore give some guidance on how to supply clinical trial material. Better guidance might be given by the Questions and Answers documents of the European Medicines Agency (EMA). In the part on supplementary requirements, Annex 13, a few Q&As are dealing with storage and transportation of IMPs.

When it comes to transport of IMPs from the manufacturer to the distributor or investigator sites, the sponsor is responsible for controlling the distribution chain and assuring “that IMPs are stored, transported, and handled in a suitable manner”. The responsibility for storage and transportation lies with the manufacturer or an importer, when the IMP comes from outside the EU. To define the specific responsibilities of the parties involved, a contract should be in place.

During storage and transportation, conditions should at least be monitored. The sponsor should define the applicable storage (and transport) conditions for the IMPs. When the IMP arrives at the investigator site, IMPs should be stored in a restricted area where appropriate, with ongoing monitoring. Everything should be defined in SOPs.

• Definition of Investigational Medicinal Products (IMPs …

  ec.europa.eu/health/files/pharmacos/…/def_imp_2006_07_27_en.pdf

  Definition of Non Investigational Medicinal Products. (NIMPs). To be included in. The rules governing medicinal products in the European Union. Volume 10.

• [PDF]

  Non Investigational Medicinal Products – European …

  ec.europa.eu/health/files/eudralex/vol-10/imp_03-2011.pdf

  Mar 18, 2011 – Guidance on investigational medicinal products (IMPs) and othermedicinal products used in clinical trials (2007). Description of changes:.

• Clinical Trials Toolkit | Investigational Medicinal Product (IMP)

  http://www.ct-toolkit.ac.uk/glossary/investigational-medicinal-product-imp

  Investigational Medicinal Product (IMP). A pharmaceutical form of an active substance or placebo being tested, or to be tested, or used, or to be used, as a …

• [PDF]

  Guidance on Investigational Medicinal Products (IMPs) and …

  http://www.meduni-graz.at/ethikkommission/Forum/…/Files/IMP_NIMP.pdf

  Guidance on Investigational Medicinal Products (IMPs) and other medicinal products used in Clinical Trials. To be included in. The rules governing medicinal …

• Good Manufacturing Practice: Investigational medicinal …

  http://www.mhra.gov.uk/Howweregulate/Medicines/…/FAQ/IMP/

  May 23, 2013 – My investigational medicinal product (IMP) unit is engaged upon reconstituting sterile injections and then giving them to the clinical trial …

• Clinical trials for medicines: Is a clinical trial authorisation …

  http://www.mhra.gov.uk/…/IsaclinicaltrialauthorisationCTArequired/

  Apr 2, 2013 – Is the product an investigational medicinal product (IMP) or a non-investigational medicinal product (NIMP)? Clinical trials in the UK are …

• Is my study a Clinical Trial of an Investigational Medicinal …

  http://www.cardiff.ac.uk/racdv/resgov/clintrials/whatis/

  Clinical Trials of Investigational Medicinal Products (CTIMPs) must also adhere to the European Clinical Trials Directive (2001/20/EC) , the Medicines for Human …

• Investigational Medicinal Products IMP – Clinical Trials Finland

  http://www.clinicaltrialsfinland.com › Services

  Based on Fimea Regulation 1/2007 ann 2/2012 (2012 only in FInnish) Clinical Trials onMedicinal Products in Human Subjects, an investigational medicinal …

• Clinical trials of investigational medicinal products (CTIMPs)

  http://www.nres.nhs.uk › … › Approval requirements › Other approvals

  Under the EU Clinical Trials Directive 2001/20/EC and the Medicines for Human Use (Clinical Trials) Regulations 2004, which transposed the Directive into UK …

• Investigational Medicinal Product Dossier (IMPD)

  http://www.impd.eu/

  The Investigational Medicinal Product Dossier is the basis for approval of clinical trials by the competent authorities in the EU. The Clinical Trials Directive …