Expiry dating of investigational medicinal products dating bricks
These questions and answers address a number of questions that have been brought to the attention of the Joint Committee for Medicinal Products for Human Use / Committee for Medicinal Products for Veterinary Use Quality Working Party (QWP) by marketing-authorisation holders (MAHs) or European Economic Area (EEA) competent authorities, on matters related to the quality of medicines.They have been developed and are maintained by the QWP.I received some IMP that had no expiry date on the packaging only on the QP release.Our Trust policy is that every medcine must have an expiry date on it so we are wrtiing it on - what are others doing in this situation???In addition, it is not clear to which extent such different appearances would have an effect on patient / user acceptability.Moreover, the introduction to the variation classification guidelines (2013/C 223/01) includes the following statement: "References in this Annex to changes to the marketing authorisation dossier mean addition, replacement or deletion, unless specifically indicated." For the purpose of illustration and comparison, change code B.They provide the EEA's harmonised position on issues that can be subject to different interpretation or require clarification, typically arising from discussions or correspondence during assessment procedures.
In this post you’ll find a series of ‘frequently asked questions’ and general answers to these.If a regulated party has questions about their legal obligations or responsibilities under the Act or Regulations, they should seek the advice of legal counsel.requires the sponsor to ensure that drugs for use in clinical trials are manufactured, handled and stored in accordance with the applicable Good Manufacturing Practices requirements referred to in Divisions 2 to 4, except for Sections C.02.019, C.02.025 and C.02.026.If further clarification is required, reference should be made to the Canadian " should be taken into account where relevant and as appropriate to the stage of development of the product.Procedures need to be flexible to provide for changes as knowledge of the process increases, and appropriate to the stage of development of the product.