Marketing Authorisation definition

Marketing Authorisation means any approval (including all applicable pricing and governmental reimbursement approvals) required from the FDA or relevant Competent Authority to market and sell a Product in a particular country.

Marketing Authorisation means those product licences and product authorisations relating to the products which enable the sale of the products in any part of the territory as granted by the relevant governmental or regulatory authorities;

Marketing Authorisation means an authorisation granted pursuant to the Med- icinal Products (Control of Placing on the Market) Regulations 2007 to 2014;

Examples of Marketing Authorisation in a sentence

• The Marketing Authorisation Holder shall have final decision making authority with respect to Product Actions and related matters, including communications with Governmental Entities and the public.

• In November 2002, OGS received Marketing Authorisation from the European Commission for Zavesca for the treatment of patients with mild to moderate Type I Gaucher disease for whom enzyme replacement therapy is unsuitable.

• The Marketing Authorisation Holder (MAH) is expected to regularly screen the worldwide scientific literature, by accessing widely used systematic literature reviews or reference databases.

• Both Parties will execute and implement a detailed pharmacovigilance agreement pertaining to Products no later than six (6) months before the earlier of the following events: (i) BI or Vitae is physically and/or legally able to distribute Products in the market, in a clinical trial or for whatever purpose, or (ii) BI or Vitae has a Marketing Authorisation Approval, a clinical trial authorisation, or has regulatory reporting obligations for any other reason.

• If, notwithstanding HPPI’s compliance with clause 5.1, a Marketing Authorisation has not been obtained by HPPI, any Affiliate or Sub Licensee at least *** before the Target Launch Date, then following consultation with the other party for up to ***, either party, acting reasonably, may terminate this agreement with immediate effect with notice to the other party.

More Definitions of Marketing Authorisation

Marketing Authorisation any approval required from a Regulatory Authority to market and sell a Product in any country.

Marketing Authorisation means, with respect to a particular country in the Territory, all marketing and other authorisations and approvals (including any required Marketing Authorisation Certificate) by the applicable Regulatory Authority in such country permitting Licensed Product to be marketed in the Field in such country including, if applicable, pricing approvals necessary to obtain reimbursement from a governmental authority.

Marketing Authorisation means the authorisation granted, under section thirty-nine, for the placement of a medicine or allied substance on the market;

Marketing Authorisation means an authorisation or licence which is for the time being in force and which has been granted by—

Marketing Authorisation means regulatory approval granted to the Licensee, any Sub-licensee or any of their respective Affiliates from the body or bodies having responsibility for the regulation of medicinal products in a particular market for Licensed Products to be marketed and sold;

Marketing Authorisation means an authorisation which is for the time being in force and which has been granted by the Authority under the Medicinal Products (Control of Placing on the Market) Regulations 2007 (S.I. No. 540 of 2007), or by the Commission under Regulation (EC) No. 726/20042and includes a marketing authorisation issued by the competent authority of an EEA State, other than the State, in accordance with Directive 2001/83/EC6;

Marketing Authorisation means any approvals, licences and permits, including any price and reimbursement approvals, required by the Regulatory Authorities in the Territory for the importation, distribution, marketing and sale of A Products and/or B Products and/or C Products in the Territory.