European Medicines Agency Sample Clauses

European Medicines Agency. ‘EU marketing authorisation’: the approval under the relevant provisions of Regulation (EC) 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervisions of medicinal products for human and veterinary use and establishing a European Medicines Agency, by the European Commission necessary for the placing on the market of the Product for vaccination in the territory of the European Union, including conditional marketing authorisation in accordance with Article 14-a of Regulation 726/2004 and Commission Regulation 507/2006/EC. ‘Final specification’: the final specification of the Product as to be determined by contractor in accordance with in Article I.6.2. ‘Force majeure’: any unforeseeable, exceptional situation or event beyond the control of the Parties that prevents either of them from fulfilling any of their obligations under the APA. The situation or event must not be attributable to error or negligence on the part of the Parties or on the part of the subcontractors and must prove to be inevitable despite their exercising due diligence. Defaults of service, defects in equipment or material or delays in making them available, labour disputes, strikes and financial difficulties may not be invoked as force majeure, unless they are caused by a relevant case of force majeure. ‘Formal notification’ (or ‘formally notify’): form of communication between the Parties made in writing by mail or e-mail in English, which provides the sender with compelling evidence that the message was delivered to the specified recipient. ‘Fraud’ : an act or omission committed in order to make an unlawful gain for the perpetrator or another by causing a loss to the Union's financial interests, and relating to: i) the use or presentation of false, incorrect or incomplete statements or documents, which has as its effect the misappropriation or wrongful retention of funds or assets from the Union budget, ii) the non-disclosure of information in violation of a specific obligation, with the same effect or iii) the misapplication of such funds or assets for purposes other than those for which they were originally granted, which damages the Union's financial interests. ‘GDP’: good distribution practices in accordance with standards currently required by EU legislation, regulation and guidance, in particular those set out in its Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for ...
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European Medicines Agency. Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells. 2018. xxxxx://xxx.xxx.xxxxxx.xx/en/documents/scientific-guideline/draft-guideline-quality-non- clinical-clinical-aspects-medicinal-products-containing-genetically_en.pdf. Accessed 01.Dec.2019.
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European Medicines Agency. Annex III: Summary of product characteristics, labelling and package leaflet - Targocid. https://xxx.xxx.xxxxxx.xx/en/medicines/human/referrals/targocid-associated- names (2014).
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European Medicines Agency. European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure. 2015;2(April):1-144.
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European Medicines Agency. Guideline on the scientific application and the practical arrangements necessary to implement commission Regulation (EC) No 507/2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC. Eur Med Agency. 2006;44(December):1-10. xxx.xxx.xxxxxx.xx/xxxx/xx_XX/...xxxxxxxxx/.../XX000000000.xxx.
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European Medicines Agency. Guideline on the scientific application and the practical arrangements necessary to implement the procedure for accelerated assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004. 2016;44(February):1-8. xxxx://xxx.xxx.xxxxxx.xx/docs/en_GB/document_library/Scientific_guideline/2016/03/WC50020277 4.pdf.
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Related to European Medicines Agency

  • Medicines To be filled in if your child requires medication as part of an individual health plan, for example for an on-going condition such as asthma or eczema etc and is for the use of that child only. For staff: Individual health plan sighted and a copy taken: Tick One: Yes No Name of medicine: Method and dose of medicine: When does the medicine need to be taken: (State time or specific symptoms) Parent/Guardian Signature: Date: / /  Enrolment Details: Date of Enrolment: / / Date of Entry: / / Date of Exit: / / Please Note: 20 Hours ECE is for up to six hours per day, up to 20 hours per week and there must be no compulsory fees when a child is receiving 20 Hours ECE funding. Days Enrolled: Monday Tuesday Wednesday Thursday Friday Times Enrolled: Total hours: For 20 Hours ECE fill out boxes below with the hours attested e.g. 6 hours 20 Hours ECE at this service Total hours: 20 Hours ECE at another service Total hours: Parent/Guardian Signature: Date: / /  20 Hours ECE Attestation:

  • European Union The academic use restriction in Section 12.d(i) below does not apply in the jurisdictions listed on this site: (xxx.xx/xxxxxxxxxxx).

  • Governing Law, Regulatory Authority, and Rules The validity, interpretation and enforcement of this Agreement and each of its provisions shall be governed by the laws of the state of New York, without regard to its conflicts of law principles. This Agreement is subject to all Applicable Laws and Regulations. Each Party expressly reserves the right to seek changes in, appeal, or otherwise contest any laws, orders, or regulations of a Governmental Authority.

  • International Bureau The International Bureau of WIPO shall perform the administrative tasks concerning the Treaty.

  • Statutory Authority Connecticut General Statute §§ 10a-104, 10a-108, 4a-52a, and 10a-151b provide the University with authority to enter into contracts in the pursuit of its mission.

  • International Organization Any international organization or wholly owned agency or instrumentality thereof. This category includes any intergovernmental organization (including a supranational organization) (1) that is comprised primarily of non-U.S. governments; (2) that has in effect a headquarters agreement with Singapore; and (3) the income of which does not inure to the benefit of private persons.

  • International Boycott Grantee certifies that neither it nor any substantially owned affiliated company is participating or shall participate in an international boycott in violation of the provision of the U.S. Export Administration Act of 1979 (50 USC Appendix 2401 et seq.) or the regulations of the U.S. Department of Commerce promulgated under that Act (15 CFR Parts 730 through 774).

  • Regulatory Authority If any regulatory authority having jurisdiction (or any successor boards or agencies), a court of competent jurisdiction or other Governmental Authority with the appropriate jurisdiction (collectively, the ''Regulatory Body'') issues a rule, regulation, law or order that has the effect of cancelling, changing or superseding any term or provision of this Agreement (the ''Regulatory Requirement''), then this Agreement will be deemed modified to the extent necessary to comply with the Regulatory Requirement. Notwithstanding the foregoing, if a Regulatory Body materially modifies the terms and conditions of this Agreement and such modification(s) materially affect the benefits flowing to one or both of the Parties, as determined by either of the Parties within twenty (20) business days of the receipt of the Agreement as materially modified, the Parties agree to attempt in good faith to negotiate an amendment or amendments to this Agreement or take other appropriate action(s) so as to put each Party in effectively the same position in which the Parties would have been had such modification not been made. In the event that, within sixty (60) days or some other time period mutually agreed upon by the Parties after such modification has been made, the Parties are unable to reach agreement as to what, if any, amendments are necessary and fail to take other appropriate action to put each Party in effectively the same position in which the Parties would have been had such modification not been made, then either Party shall have the right to unilaterally terminate this Agreement forthwith.

  • Department of Justice Xxxx X. Xxxxxxx Student Loan Repayment Program (JRJSLRP) Service Agreement – Secondary Term of Service NAME: In consideration of the student loan repayment incentive for which I may qualify under 34 U.S.C. §10671, such incentive having been offered above and beyond the incentive(s) from which I have already benefitted from in exchange for a term of service that I have fulfilled, I hereby agree as follows:

  • Notice to European Union Users TwoByrdz's operations are located primarily in the United States. If you provide information to us, the information will be transferred out of the European Union (EU) and sent to the United States. (The adequacy decision on the EU-US Privacy became operational on August 1, 2016. This framework protects the fundamental rights of anyone in the EU whose personal data is transferred to the United States for commercial purposes. It allows the free transfer of data to companies that are certified in the US under the Privacy Shield.) By providing personal information to us, you are consenting to its storage and use as described in this Policy. Your Rights as a Data Subject Under the regulations of the General Data Protection Regulation ("GDPR") of the EU you have certain rights as a Data Subject. These rights are as follows: · The right to be informed: this means we must inform you of how we intend to use your personal data and we do this through the terms of this Policy. · The right of access: this means you have the right to request access to the data we hold about you and we must respond to those requests within one month. You can do this by sending an email to Xxxxxxx@xxxxxxxx.xxx. · The right to rectification: this means that if you believe some of the date, we hold is incorrect, you have the right to have it corrected. You can do this by logging into your account with us, or by sending us an email with your request. · The right to erasure: this means you can request that the information we hold be deleted, and we will comply unless we have a compelling reason not to, in which case you will be informed of same. You can do this by sending an email to Xxxxxxx@xxxxxxxx.xxx. · The right to restrict processing: this means you can change your communication preferences or opt-out of certain communications. You can do this by sending an email to Xxxxxxx@xxxxxxxx.xxx. · The right of data portability: this means you can obtain and use the data we hold for your own purposes without explanation. If you wish to request a copy of your information, contact us at Xxxxxxx@xxxxxxxx.xxx. · The right to object: this means you can file a formal objection with us regarding our use of your information with regard to third parties, or its processing where our legal basis is our legitimate interest in it. To do this, please send an email to Xxxxxxx@xxxxxxxx.xxx. In addition to the rights above, please rest assured that we will always aim to encrypt and anonymize your personal information whenever possible. We also have protocols in place in the unlikely event that we suffer a data breach and we will contact you if your personal information is ever at risk. For more details regarding our security protections see the section below or visit our website at XxxXxxxx.xxx.

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