Safeguard Clause. 1. Notwithstanding Article 24, after having examined alternative solutions, a Party may apply safeguard measures of limited duration which derogate from the provisions of Article 15 or 16 as the case may be, under the conditions and in accordance with the procedures laid down in this Article.
2. Safeguard measures referred to in paragraph 1 may be taken where a product originating in one Party is being imported into the territory of the other Party in such increased quantities and under such conditions as to cause or threaten to cause:
(a) serious injury to the domestic industry producing like or directly competitive products in the territory of the importing Party; or
(b) disturbances in a sector of the economy, particularly where these disturbances produce major social problems, or difficulties which could bring about serious deterioration in the economic situation of the importing Party, or
(c) disturbances in the markets of like or directly competitive agricultural products 1 or in the mechanisms regulating those markets.
3. Safeguard measures referred to in this Article shall not exceed what is necessary to remedy or prevent the serious injury or disturbances, as defined in paragraph 2. Those safeguard measures of the importing Party may only consist of one or more of the following:
(a) suspension of the further reduction of the rate of import duty for the product concerned, as provided for under this Agreement,
(b) increase in the customs duty on the product concerned up to a level which does not exceed the customs duty applied to other WTO Members, and
(c) introduction of tariff quotas on the product concerned.
4. Without prejudice to paragraphs 1 to 3, where any product originating in one or more Signatory CARIFORUM State(s) is being imported in such increased quantities and under such conditions as to cause or threaten to cause one of the situations referred to under paragraphs 2(a), (b) and (c) to one or several of the EC Party's outermost regions, the EC Party may take surveillance or safeguard measures limited to the region or regions concerned in accordance with the procedures laid down in paragraphs 6 to 9.
1 For the purpose of this Article agricultural products are those covered by Annex I of the WTO Agreement on Agriculture.
(a) Without prejudice to paragraphs 1 to 3, where any product originating in the EC Party is being imported in such increased quantities and under such conditions as to cause or threaten to cause one of the situations r...
Safeguard Clause. 1. Where, in exceptional circumstances, automatic recognition pursuant to Article 3 of this Treaty causes, or threatens to cause, substantial difficulties for the higher education system of a Party, that Party may take safeguard measures with regard to the qualification or qualifications concerned, provided that such measures are strictly necessary and that they remain without prejudice to the relevant provisions and principles of the Lisbon Recognition Convention and its subsidiary texts, the relevant provisions of other applicable arrangements and the relevant provisions of the legislation of the Party concerned.
2. As soon as a Party takes safeguard measures pursuant to paragraph 1 of this Article, it shall liaise with the Party or Parties where the qualification or qualifications concerned have been issued, in order to resolve the situation. It shall also notify these measures to the Depositary, who shall inform all other Parties thereof.
3. All Parties shall at all times remain vigilant to avoid any misuse of the present Treaty, in particular to prevent that recognition decisions taken prior to the entry into force of this Treaty would be overridden. In the event of known abuse, the Party concerned shall take all necessary measures in order to exclude the related cases from the application of the present Treaty. That Party shall also notify these cases to the Depositary, who shall inform all other Parties thereof.
Safeguard Clause. 1. Where any product is being imported in such increased quantities and under such conditions as to cause or threaten to cause serious injury to domestic producers of like or directly competitive products in the territory of one of the Contracting Parties, the Community or South Africa, whichever is concerned, may take appropriate measures under the conditions provided for in the WTO Agreement on Safeguards or the Agreement on Agriculture annexed to the Marrakech Agreement establishing the WTO and in accordance with the procedures laid down in Article 26.
2. Where any product is being imported in such increased quantities and under such conditions as to cause or threaten to cause serious deterioration in the economic situation of the European Union's outermost regions, the European Union, after having examined alternative solutions, may exceptionally take surveillance or safeguard measures limited to the region(s) concerned, in accordance with the procedures laid down in Article 26.
3. Where any product is being imported in such quantities and under such conditions as to cause or threaten to cause serious deterioration in the economic situation of one or more of the other Members of the Southern African Customs Union, South Africa, at the request of the country or countries concerned, and after having examined alternative solutions, may exceptionally take surveillance or safeguard measures in accordance with the procedures laid down in Article 26.
Safeguard Clause. 1. Each Party recognizes that the importing country has a right to fulfil its legal responsibilities by taking actions necessary to ensure the protection of human and animal health at the level of protection it deems appropriate. An authority of a Party has the right to conduct its own inspection of a manufac- turing facility in the territory of the other Party.
2. An authority of a Party conducting its own inspection of a manufacturing facility in the territory of the other Party should be an exception from the normal practice of a Party as of the date on which the Articles referred to in Article 19(2)
Safeguard Clause. 1. In the event of serious disturbances occurring in the economy of a Member State following the application of the provisions of this Chapter, the Member State concerned shall, after informing the Secretary-General and the other Member States, take necessary safeguard measures.
2. Safeguard measures taken under the provisions of paragraph 1 of this Article, shall remain in force for a period of one year and may be extended by the decision of the Council provided that the Member State concerned shall furnish to the Council proof that it has taken the necessary and reasonable steps to overcome or correct imbalances for which safeguard measures are being applied and that the measures applied are on the basis of non-discrimination.
3. The Council shall examine the method and effect of the application of existing safeguard measures and take a decision thereon.
Safeguard Clause. 1. Unless otherwise provided by this Article, the provisions of Article XIX of the GATT 1994 and of the WTO Agreement on Safeguards are applicable between the Parties. The provisions of paragraphs 2, 3, 4, 5, 7, 8 and 9 of this Article apply only when a Party has a substantial interest as exporter of the product concerned, as defined in paragraph 10.
2. Each Party shall provide, immediately and in any case no later than seven days from the event, ad hoc written notification to the Association Committee of all pertinent information on the initiation of a safeguard investigation and on the final findings of the investigation.
3. The information provided under paragraph 2 shall include in particular an explanation of the domestic procedure on the basis of which the investigation will be carried out and an indication of the time schedules for hearings and other appropriate opportunities for interested parties to present their views on the matter. Furthermore, each Party shall provide advance written notification to the Association Committee of all pertinent information on the decision to apply provisional safeguard measures. Such notice must be received at least seven days before the application of such measures.
4. Upon notification of the final findings of the investigation and before applying safeguard measures pursuant to the provisions of Article XIX of the GATT 1994 and of the WTO Agreement on Safeguards, the Party intending to apply such measures shall refer the matter to the Association Committee for a thorough examination of the situation with a view to seeking a mutually acceptable solution. In order to find such a solution and if the Party concerned so requests, the Parties shall hold prior consultations within the Association Committee.
5. Notwithstanding paragraph 4, nothing shall prevent a Party from applying measures pursuant to the provisions of Article XIX of the GATT 1994 and of the WTO Agreement on Safeguards.
6. In the selection of safeguard measures referred to in this Article, the Parties shall give priority to those which cause least disturbance to the achievement of the objectives of this Agreement. Such measures shall not exceed what is necessary to remedy the serious injury, and shall preserve the level/margin of preference granted under this Title.
7. The Parties confirm their rights and obligations under paragraphs 1 and 2 of Article 8 of the WTO Safeguard Agreement.
8. The right of suspension referred to in Article 8(2) of the WTO ...
Safeguard Clause. 18.1. The legal invalidity of individual provisions of the General Terms & Conditions for Sales & Delivery or other contracts between HSA Systems and Customer does not affect the validity of the General Terms & Conditions for Sales & Delivery as a whole.
Safeguard Clause. The parties hereby expressly agree that, should the market conditions change in such a way as to cause a serious harm to either party while the sale contract is being implemented, they shall consult each other in order to take necessary steps to re-establish the equilibrium of the sale contract within the spirit which prevailed initially.
Safeguard Clause. If any provision of these contractual terms and conditions or of the contractual principles listed in clause 1 should be ineffec- tive, this shall not affect the validity of the remaining provisions.
Safeguard Clause. Each Party recognises that the importing country has a right to fulfil its legal responsibilities by taking actions necessary to ensure the protection of human and animal health at the level of protection it deems appropriate. This includes the suspension of the distribution, product detention at the border of the importing country, withdrawal of the batches and any request for additional information or inspection as provided in Article 12. Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, as extended, widened and amended. Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, as extended, widened and amended. Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products, as widened and amended. Council Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use. Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products. Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products. Council Directive 92/25/EEC of 31 March 1992 on the wholesale distribution of medicinal products for human use. Guide to Good Distribution Practice (94/C 63/03). Current version of the Guide to Good Manufacturing Practice, Rules Governing Medicinal Products in the European Community, Volume IV. Relevant sections of the United States Federal Food, Drug, and Cosmetic Act and the United States Public Health Service Act. Relevant sections of Title 21, United States Code of Federal Regulations (CFR) Parts 1-99, Parts 200-299, Parts 500-599, and Parts 600-799. Relevant sections of the FDA Investigations Operations Manual, the FDA Regulatory Procedures Manual, the FDA Compliance Policy Guidance Manual, the FDA Compliance Program Guidance Manual, and other FDA guidances.
