Marketing Authorisation Holder definition

Marketing Authorisation Holder means the holder of the relevant Marketing Authorisation;
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Marketing Authorisation Holder means, in respect of a Marketing Authorisation, the holder of such Marketing Authorisation from time to time.
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Marketing Authorisation Holder means a manufacturer or supplier that holds a marketing authorisation;
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Examples of Marketing Authorisation Holder in a sentence

  • SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/risk profile.

  • If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time • Additional risk minimisation measuresPrior to launch of the new indication of the product in each Member State, the Marketing Authorisation Holder shall agree the content and format of the educational material with the national competent authority.

  • NAME OF THE MARKETING AUTHORISATION HOLDER <[To be completed nationally]> [For MRP/DCP procedures]<[See Annex I - To be completed nationally]> [For referral procedures] [This statement should be included for all types of referrals] {Name} [Full/short name of the Marketing Authorisation Holder.] 3.

  • Strength: Pharmaceutical Form: 3a: Marketing Authorisation Holder in country of licensing: 3b: MA/AA/PI /EU No (Delete as applicable) 4: Country of licensing: 5: Pack size: 6: Product complies with the latest edition of : Ph Eur:  BP:  USP:  Company in-house Monograph:  OTHERS (specify) : N.B. Any variation from the published specifications, must be clearly specified.

  • Number to be completed by the Marketing Authorisation Holder, reflecting the correct sequential MRP/DCP Number according to Volume 2A, Chapter 2, 7.

  • In exceptional circumstances, a Marketing Authorisation Holder (MAH) may request a change of the Reference Member State (RMS).

  • The competent authority, in the role of the RMS in a planned variation procedure, should agree with the Marketing Authorisation Holder (MAH) on the timetable of the procedure and aim to synchronise the possible parallel or sequential variation procedures so that overlapping of procedures is avoided, where practical.

  • The Marketing Authorisation Holder (MAH) should ensure that, at launch of the new indication, all Healthcare Professionals who are expected to use and/or prescribe INOmax as part of the treatment of peri- or post- operative pulmonary hypertension in adults and children in conjunction to heart surgery are provided with an Educational pack.

  • For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder (CIS bio international).

  • 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.


More Definitions of Marketing Authorisation Holder

Marketing Authorisation Holder means a legal person seated in the Republic of Croatia holding an authorisation for the marketing of a drug product in the Republic of Croatia,
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Marketing Authorisation Holder means the holder of a marketing authorisation, as defined in Regulation 3(1) of the Medicinal Products (Control of Placing on the Market) Regulations 2007 (S.I. No. 540 of 2007);
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Marketing Authorisation Holder means any natural or legal person established in the European Union that is in possession of a marketing authorisation issued by the Agency for medicinal products and medical devices or the European Commission and that is responsible for placing medicinal products on the market,
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Marketing Authorisation Holder means a natural or legal person in possession of a licence or marketing authorization issued by the Board for a Pharmaceutical Product to be marketed in Southern Sudan
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Marketing Authorisation Holder. (MAH) means the Party named on the Marketing Authorisation for a specific product in a particular country
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Marketing Authorisation Holder shall in all text refer to Licensor.
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Related to Marketing Authorisation Holder

  • Marketing Authorisation means, with respect to a country, region or other jurisdiction in the Territory, any and all approvals (including Drug Approval Applications), licenses, registrations, or authorisations of any Regulatory Authority necessary to commercially distribute, sell, or market Product in such country or other jurisdiction, including, where applicable, (a) pre- and post-approval regulatory approvals (including any prerequisite manufacturing approval or authorisation related thereto), and (b) approval of Product labelling.

  • Safety Authorisation and “deemed Safety Authorisation” have the meanings given to “safety authorisation” and “deemed safety authorisation” by the Railways and Other Guided Transport Systems (Safety) Regulations 2006;

  • Marketing Authorization means all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacturing, use, storage, import, transport, marketing and sale of Licensed Products in a country or regulatory jurisdiction.

  • Required Authorisation means any authorisation, consent, declaration, licence, permit, exemption, approval or other document, whether imposed by or arising in connection with any law, regulation, custom, contract, security or otherwise howsoever which must be obtained at any time from any person, Government Entity, central bank or other self-regulating or supra-national authority in order to enable the Borrowers lawfully to borrow the loan or draw any Advance and/or to enable any Security Party lawfully and continuously to continue its corporate existence and/or perform all its obligations whatsoever whensoever arising and/or grant security under the relevant Security Documents and/or to ensure the continuous validity and enforceability thereof;

  • Authorisation means an authorisation, consent, approval, resolution, licence, exemption, filing, notarisation or registration.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • Authorisations means any consent, registration, filing, notarisation, licence, approval, permit, authority or exemption from, by or with any Governmental Authority and all corporate, creditors’, shareholders’ and third-party approvals or consents;

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • Regulatory Approval means any and all approvals (including MAA Approval, and Pricing and Reimbursement Approval, if applicable), licenses, registrations, permits, notifications and authorizations (or waivers) of any Regulatory Authority that are necessary for the manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for sale, sale or other commercialization of a Product in any country or jurisdiction.

  • Tax Filing Authorised Person means such person as any Director shall designate from time to time, acting severally.

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • Relevant Supervisory Consent means, in relation to any redemption or purchase of the Notes, any required permission of the Relevant Regulator applicable to the Company or the Relevant UK Resolution Authority (as applicable). For the avoidance of doubt, Relevant Supervisory Consent will not be required if either (i) none of the Debt Securities qualify as part of the Issuer’s regulatory capital, or own funds and eligible liabilities or loss absorbing capacity instruments, as the case may be, each pursuant to the Loss Absorption Regulations, (ii) the relevant Debt Securities are repurchased for market-making purposes in accordance with any permission given by the Relevant Regulator pursuant to the Loss Absorption Regulations within the limits prescribed in such permission or (iii) the relevant Debt Securities are being redeemed or repurchased pursuant to any general prior permission granted by the Relevant Regulator or the Relevant UK Resolution Authority (as applicable) pursuant to the Loss Absorption Regulations within the limits prescribed in such permission.

  • Public Procurement Regulatory Authority (PPRA) means the Government Agency responsible for oversight of public procurement.

  • Initial approval means authorization to admit students and enter into contractual agreements for clinical facilities. It is granted only after an application has been submitted, reviewed and a survey visit made by the Board. No students shall be admitted to the program until the institution has received written notification that initial approval has been granted. Failure to comply will delay initial approval.

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • Product Approval means the approval of a Governmental Authority necessary for the marketing and sale of the Product in a given country or regulatory jurisdiction, which may include the approval of an MAA (but shall not include any Pricing Approvals).

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Governmental Approval is any consent, authorization, approval, order, license, franchise, permit, certificate, accreditation, registration, filing or notice, of, issued by, from or to, or other act by or in respect of, any Governmental Authority.

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

  • Regulatory Authorizations means all approvals, clearances, authorizations, registrations, certifications, licenses and permits granted by any Regulatory Authority, including all INDs and NDAs.

  • the Scottish Infected Blood Support Scheme means the scheme of that name administered by the Common Services Agency (constituted under section 10 of the National Health Service (Scotland) Act 1978(b));

  • Conditional approval means a time-limited status that results when an approved nursing education program has failed to maintain requirements as set forth in this chapter.

  • CFDA means the Code of Federal Domestic Assistance assigned to a federal grant.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale of a Product as a pharmaceutical product in a regulatory jurisdiction.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.