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EMA/199678/2016: Reflection paper on extrapolation of efficacy and safety in paediatric medicine development. [8] EMA/189724/2018: Reflection paper on the use of extrapolation in the development of medicines for paediatrics. [9] EMA/129698/2012: Concept paper on extrapolation of efficacy and safety in medicine development. [10]
Modified atmosphere/modified humidity (MA/MH) packaging is a type of equilibrium modified atmosphere packaging (EMAP), which evolved due to the need for more control of humidity in the packaging. Most of the polymers that are commercially used in EMAP are polyolefin -based, characterized by low moisture vapor transmission rate (MVTR).
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency ( EMEA ).
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]).
Recycling codes on products. Recycling codes are used to identify the materials out of which the item is made, to facilitate easier recycling process.The presence on an item of a recycling code, a chasing arrows logo, or a resin code, is not an automatic indicator that a material is recyclable; it is an explanation of what the item is made of.
The European Packaging and packaging waste directive 94/62/EC (1994) deals with the problems of packaging waste and the currently permitted heavy metal content in packaging. The Directive obligates member states to meet targets for the recovery and recycling of packaging waste. The Directive covers all packaging placed on the Community market.
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
The child-resistant locking closure for containers was invented in 1967 by Dr. Henri Breault. [7]A history of accidents involving children opening household packaging and ingesting the contents led the United States Congress to pass the Poison Prevention Packaging Act of 1970, authored by U.S. Senator Frank E. Moss of Utah.