Investigational Medicinal Product definition

Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

Investigational Medicinal Product means a medicinal product which is being tested or used as a reference, including as a placebo, in a clinical trial;

Investigational Medicinal Product or “IMP” has the same meaning as that ascribed to that phrase in the CTOA.

Examples of Investigational Medicinal Product in a sentence

• This section does however allow Sponsors to state, for example, that when they expect training in Good Clinical Practice for appropriate team members where the study is a Clinical Trial of an Investigational Medicinal Product, they will accept UK nationally recognised GCP training, training recognised on the Transcelerate mutual recognition scheme, etc.

• The Trust will not, and will ensure that the Investigator and Trial Site Team Members do not, use the name of the Sponsor or CRO or any of their employees, nor the name of the Clinical Trial, nor the name of the Investigational Medicinal Product, in any publicity, advertising or news release without the prior written approval of the Sponsor or CRO as appropriate, such approval not to be unreasonably withheld.

• Therefore, the proposed actions should focus on late preclinical (e.g. validation in animal models, toxicology, Good Manufacturing Practices (GMP) production, preparation of Investigational Medicinal Product Dossier) and early clinical (up to phase 1) development of already existing lead drug and vaccine candidates.

• The Board will not, and will ensure that the Investigator and Trial Site Team Members do not, use the name of the Sponsor or CRO or any of their employees, nor the name of the Clinical Trial, nor the name of the Investigational Medicinal Product, in any publicity, advertising or news release without the prior written approval of the Sponsor or CRO as appropriate, such approval not to be unreasonably withheld.

• This is a Clinical Trial of an Investigational Medicinal Product (IMP) as defined by the EU Directive 2001/20/EC.

More Definitions of Investigational Medicinal Product

Investigational Medicinal Product means a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form,

Investigational Medicinal Product means any product as defined in Article 2(d) of Directive 2001/20/EC;

Investigational Medicinal Product means a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including a medicinal product that is already the subject of a marketing authorisation, but—

Investigational Medicinal Product means a pharmaceutical form of an active substance or placebo being tested, or to be tested, or used, or to be used, as a reference in a clinical trial, and includes a medicinal product which has a marketing authorization but is, for the purposes of the trial—

Investigational Medicinal Product means TKM-Ebola presented in wet format, targeting the Guinea variant of the Ebola virus having the product description set forth in Exhibit 1.1.38.

Investigational Medicinal Product means any pharmaceutical product or placebo being tested or used as a reference in a clinical trial.

Investigational Medicinal Product. (or “IMP”): the pharmaceutical compound xxxxxxx xxxxxxxxx which is under investigation according to the Protocol. (b) „hodnocený léčivý přípravek“: léčivá xxxxx/y xxxxxxxxxxxxxxxxx, hodnocená v souladu s protokolem.