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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.
Open-dish studies at 25 °C/60% RH are considered to be acceptable without further justification as constant exposure to humidity can be regarded as a worst-case scenario.
No, this decision is not at the applicant’s discretion.
Such limitations should be introduced only when strictly necessary, due to the possible implications of in-use shelf lives to patients and to the National Health Care Systems.1.
No specific requirements or recommendations are provided in the European Union guideline on plastic immediate packaging materials, CPMP/QWP/4359/03 and EMEA/CVMP/205/04, in regard to acceptable quality standards for plastic materials to be used for containers for solid oral dosage forms and solid active substances. Materials with a different formulation, complying with a different specification may be used, if justified, and subject to agreement by the competent authority.
In case more than one active substance produced at different manufacturing sites is mixed together at a different manufacturing site, is it possible to consider the mixing as active substance manufacture? The mixing of active substances that can exist and are produced on their own should be considered as the first step of the manufacture of the finished product.Such confusion is considered to have a negative effect on therapeutic adherence and therefore considered as a risk to public and/or animal health.Acceptance of such different tablet appearances in the specification of a single strengthproduct would formally also allow the company to dispense these two appearances in the same container/blister, which may even cause greater confusion.II.a.1 (Change or addition of imprints, bossing or other markings including replacement, or addition of inks used for product marking.) includes specific reference to addition, which means that tablet markings can be added if not currently present. II.a.2 (Change in the shape or dimensions of the pharmaceutical form) does not include any reference to addition.Therefore, in view of this specific absence and taking into account the highlighted introductory text, this could be interpreted as meaning that any change to the shape or dimensions of the pharmaceutical form cannot include the addition of an additional/alternative shape but only replacement.
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.