Pharmaceutical Law definition

Pharmaceutical Law means any federal, state, local or foreign law, statute, rule or regulation relating to the development, commercialization and sale of pharmaceutical and biotechnology products and devices, including all applicable regulations of the U.S. Food and Drug Administration and comparable applicable foreign regulatory authorities.
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Pharmaceutical Law shall have the meaning set forth in Section 5.1(i)(i).
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Examples of Pharmaceutical Law in a sentence

  • Borrowers and Guarantors have obtained all permits, licenses and other authorizations which are required with respect to the ownership and operations of their business under any Pharmaceutical Law, except where the failure to obtain such permits, licenses or other authorizations would not reasonably be expected to have a Material Adverse Effect.

  • Seller has not received any written, or, to Seller’s Knowledge, other notice from the FDA or any other Governmental Authority alleging noncompliance with any Pharmaceutical Law or initiating, or threatening to initiate, any action to suspend or terminate a Product IND.

  • PBKM informs and reserves, while the Parents acknowledge that the stored MSCs isolated from the umbilical cord tissue do not constitute a medicinal product ready to administer, and they are only a primary culture material that may be used as a basis to create MSC cell preparation constituting an advanced therapy medicinal product as defined in Article 2 (33b) of the Pharmaceutical Law Act (Polish Journal of Laws of 2022 item 2301).

  • DSM shall be responsible for Manufacturing all Product hereunder in accordance with Applicable Pharmaceutical Law.

  • Periodic re-certification of methods validations may be required in accordance † DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION with Applicable Pharmaceutical Law.

  • Neither the Borrower nor any of its Subsidiaries has any liabilities, claims against it or presently outstanding notices imposed or based upon any provision of any Pharmaceutical Law in any material respect.

  • KGbio is a biotechnology company established in 2016, its business model revolves around in-licensing novel biologics and select biosimilars in oncology and high-specialty therapeutic areas (typically pre-IND or early clinical stage), with the objective to out- license them in target geographies after finishing clinical development as well as regulatory and reimbursement approvals.

  • It was transposed into German law on 19 October 2012 with the “Second Amendment Act for Pharmaceutical Law and other Regulations“.

  • According to Section 15a of the Pharmaceutical Law, which had been introduced to implement a provision of EU-Directive 65/65, a new applicant may claim reference to parts of files concerning already approved pharmaceuticals if the first applicant agrees or the first approval has taken place 6 years (respectively 10 years in regard to special products) ago in a member state of the EEA-Agreement.

  • The Parties also agree that if a Product Addendum specifies Japan as an Agreed Additional Compliance Region then Applicable Pharmaceutical Law for Manufacturing pursuant to such Product Addendum shall also include (i) legislation, rules and guidances promulgated, adopted or enforced by the Japanese Ministry of Health, Labour, and Welfare, including through its Pharmaceutical and Food Safety Bureau, Health Policy Bureau and Pharmaceuticals and Medical Devices Evaluation Center.