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Download as PDF; Printable version; ... Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03) ... (European Commission) This page ...
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate and partial agreement of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the Council of Europe in 1964: ETS 50, [2] Protocol [3]).
Directive 92/58/EEC; European Union directive: Title: COUNCIL DIRECTIVE 92/58/EEC of 24 June 1992 on the minimum requirements for the provision of safety and/or health signs at work (ninth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC)
According to EU Law the European Commission had to decide on the fate of the EMA's location. The EU ministers met to vote on their preferred successor. [ 28 ] The EU's Health Commissioner Vytenis Andriukaitis said that the preferred choice would be a location where an "easy set up and guarantee of smooth operations" would be available.
The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide ...
Voltage dips, short interruptions and voltage variations immunity tests for equipment with mains current more than 16 A per phase; IEC 61000-5-1 Electromagnetic compatibility (EMC). Installation and mitigation guidelines. General considerations. Basic EMC publication; EN 61000-5-5 Electromagnetic compatibility (EMC). Installation and mitigation ...
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The parties can at any time agree to change the applicable law and any such variation will not prejudice the formal validity of the agreement nor adversely affect the rights of third parties. Where all the elements of a contract, at the time of its conclusion, are connected with only one country, Article 3 may not be used to evade the mandatory ...