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This guideline provides advice on the viral safety data and documentation that should be submitted in a request for authorisation of a clinical trial of a human biotechnological medicinal product. The guideline provides for a harmonised approach throughout the European Union, for both sponsors and regulators, with regard to the assessment of viral safety of biotechnological IMPs during clinical development. This will be especially beneficial for multi-centre studies, potentially involving several different member states.

This guideline applies to human biotechnological IMPs prepared from cells cultivated in vitro from characterised cell banks of human or animal origin as described in Q5A. Many IMPs are derived from well-characterised rodent cell lines such as CHO, NS0 or SP2/0, although a variety of other cell lines are in use and under development and should be considered on a case-by-case basis.

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This guideline is applicable to the manufacture of the finished dosage form of chemical and herbal medicinal products for human use intended for marketing authorisation. It also applies to variations for authorised products in cases where changes to the manufacturing process affecting the MA are proposed.

The principles described are in general also applicable to biological medicinal products. Where relevant, the principles of this guideline may also be applied to radiopharmaceuticals and to chemical investigational medicinal products.

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This guideline provides recommendations for the validation of bioanalytical methods applied to measure drug concentrations in biological matrices obtained in animal toxicokinetic studies and all phases of clinical trials. As ligand binding assays differ substantially from chromatographic analytical methods, separate validation recommendations for ligand binding assays are provided.

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Tissue establishments, through the responsible person (or designee), are responsible for notifying and providing the HPRA with a report analysing the cause and ensuing outcome of:
– any SAR or SAE which may influence the quality and safety of tissues and cells and which may be attributed to the procurement, testing, processing, preservation, storage and distribution of tissues and cells. (This includes ‘near miss’ reports where the event was detected prior to transplantation.)
– any SARs observed during or after clinical application which may be linked to the quality and safety of tissues and cells.

Note: Serious Adverse Reaction/Event Report Form – Human Tissues and Cells has been attached.

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A biosimilar is a biological medicine that is highly similar to another biological medicine (reference medicinal product) which already has a marketing authorisation and has been approved for use in patients. As such, biosimilars contain a version of the active substance of an approved biological medicine and generally should be used in the same way for its own
approved indications.

The purpose of this guide is to provide an overview of the regulatory processes through which the quality, safety and efficacy of biosimilar medicines is assessed prior to gaining marketing authorisation. The guide is primarily aimed at healthcare professionals for the purpose of informing and assisting their decision making processes when prescribing and
dispensing medicines of this nature.

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Below listed chapters are included in this guideline:

  1. Authorisation or registration of medicines
  2. Clinical trial authorisations
  3. Manufacturers’/Importers’ authorisations and wholesale distributor authorisations
  4. Blood and tissue establishments and organ authorisations
  5. Exempt medicinal products
  6. Cosmetics
  7. Precursor chemicals
  8. Medical devices
  9. Miscellaneous fees

Note: Fee Application Form for Human Products has been attached.

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This guideline is having following parts:

  1. Regular quality control of a medicinal product
  2. Special quality control of a medicinal product
  3. Quality control of medicinal products that are on the market
  4. Extraordinary quality control of medicinal products
  5. Quality control of a medicinal product during the procedure for the granting or renewal of a marketing authorisation or an authorisation for parallel import of a medicinal product and during the procedure for approval of a variation to the dossier of a medicinal product
  6. Method of quality control of medicinal products
  7. Sampling
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The Norwegian Medicines Agency follows the EC administrative procedure for Official control authority batch release.

The EC administrative procedure for Official control authority batch release is a guideline for the administrative procedure to be followed by the competent OMCL authorities for the implementation of Directive 2001/83/EC Article 114 as amended by Directive 2004/27/EC and published by the European Directorate for the Quality of Medicines & HealthCare (EDQM).

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