MAA Approval definition

MAA Approval means the Approval of an MAA by the EMA for a Product in any country in the EU.

MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

MAA Approval means approval by the EMEA of a marketing authorization application (“MAA”) filed with the EMEA for the applicable Licensed Product under the centralized European procedure. If the centralized EMEA filing procedure is not used, MAA Approval shall be achieved upon the first Approval for the applicable Licensed Product in any two of the following countries: France, Germany, Italy, Spain or the United Kingdom.

Examples of MAA Approval in a sentence

• Where sufficient flight operations experience cannot be vested in one person, multiple flight operations post-holders may be nominated, each requiring MAA Approval for their intended role.36.

• The GDP shall set forth the timeline and details (including line of therapy, tumor type, primary endpoints, approximate patient size, combination agents and comparator agents) of all preclinical and clinical Development activities to be conducted by the Parties as necessary to generate Data sufficient to meet the common requirements of both the EMA and FDA for MAA Approval of the Compound and Products for RCC, HCC, and other indications agreed upon by the Parties.

• VIVUS may terminate this Agreement on a country-by-country basis on thirty (30) days notice if MAA Approval has not been received in such county within four (4) years from the Effective Date; provided such notice is given prior to obtaining such MAA Approvals.

• However, it is unlikely that significant exposure between sediment and receptors of concern will occur.

• With only one person, the requirement for a separate record of authorization is unnecessary because the MAA Approval Schedule defines the authorization.

More Definitions of MAA Approval

MAA Approval shall be achieved upon receiving Regulatory Approval of an MAA and, where applicable, receipt of pricing and reimbursement approvals, for the applicable Product in a Major European Country.

MAA Approval means, with respect to each country or region, approval of the applicable MAA by the applicable Regulatory Authority.

MAA Approval means, with respect to a particular country in the TERRITORY, approval by the applicable REGULATORY AUTHORITIES in such country of an MAA filed in such country, permitting PRODUCT to be marketed in that country for the indication(s) for which approval is sought, including, if applicable, approval of pricing or reimbursement.

MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the applicable country or jurisdiction, but excluding any Pricing and Reimbursement Approval.

MAA Approval means Approval by the EMA of a MAA filed with the EMA for the applicable Licensed Product under the centralized European procedure. If the centralized EMA filing procedure is not used, MAA Approval shall be achieved upon the first Approval for the applicable Licensed Product in three of the following countries: France, Germany, Italy, Spain and the United Kingdom. For clarity, MAA Approval shall include any pricing and reimbursement approvals required prior to sale of such Licensed Product in the European Union, or in connection with Approvals achieved in three of the foregoing five European Union member states; provided, that MAA Approval shall in any event be deemed achieved upon First Commercial Sale in any country in the European Union.

MAA Approval means, with respect to each country of the Territory for a particular Product, approval of the MAA filed in such country by the health regulatory authority in such country that is the counterpart of the U.S. FDA. It is understood that MAA Approval does not include pricing or reimbursement approval. In any event, MAA Approval shall be deemed to have occurred in a country with respect to a Product no later than the date of the First Commercial Sale of such Product in such country by or under authority of Janssen or its Subdistributors.

MAA Approval means Marketing Authorization Application approval by the appropriate regulatory agency(ies) for commercialization of a Compound or Product in a Major European Country.