Search results with tag "Medicinal products"
Introduction to ISO Identification of Medicinal Products ...
www.ema.europa.euIntroduction to ISO Identification of Medicinal Products (IDMP), SPOR programme EMA/732656/2015 Page 3/12 . 1. Executive summary. The International Organisation for Standardisation (ISO), Identification of Medicinal Products (IDMP) standards specify the use of standardised definitions for the identification and description of medicinal
Regulation on the Registration of Medicinal Products for ...
titck.gov.trquality in medicinal products for human use. Scope Article 2-This Regulation shall comprise medicinal products for human use which are manufactured industrially or imported and the real and legal persons who have applied for the registration and/or have been granted the registration of such products.
Chapter 4 Final 0910 - European Commission
ec.europa.eu2001/82/EC on the Community code relating to veterinary medicinal products. This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use.
Guide to Application for Registration of Medicinal Products
moh.gov.bnregistration system of all medicinal products for human use prior to their use in Brunei Darussalam. Medicinal products in Brunei Darussalam are regulated under the Medicines Order 2007, Medicines (Licensing, Standard Provision and Fees) Regulations 2010, Medicines (Labelling) Regulations
The Medical Devices Regulations 2002 - Legislation.gov.uk
www.legislation.gov.ukas regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use and Directive 2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use];
Guideline on the exposure to Medicinal Products during ...
www.ema.europa.eua medicinal product and the doses and concentrations at which such effects will develop, it is desirable to gather information about all medicinal products taken by pregnant women. 2.2 Assessing the need for information on drug exposure It is good practice to always try to collect information on medicinal exposure during pregnancy.
Guideline on Compassionate use of Medicinal Products
www.ema.europa.euthe criteria and conditions for the compassionate use of new medicinal products under MS’ legislation”. Article 83 (1) of Regulation (EC) No 726/2004 introduces the legal framework for the provision of compassionate use in the European Union for medicinal products that are eligible to be authorised via
Lists of medicinal products for rare diseases in Europe*
www.orpha.netAnnex 2: Orphan medicinal products withdrawn from use in the European Union 32 Classificationby date of MA in descending order 34 Classification by ATC category 35 Classification by MA holder 36 Methodology This part of the document provides the list of all orphan medicinal products that have received a European Marketing
Guideline on setting health based exposure limits for use ...
www.ema.europa.euCommittee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterinary Use (CVMP) Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities . Draft Agreed by Safety Working Party .
E 2 A Clinical Safety Data Management: Definitions and ...
www.ema.europa.euThe phrase "responses to a medicinal products" means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out. Regarding marketed medicinal products, a …
Guideline on the clinical development of medicinal ...
www.ema.europa.euGuideline on the clinical development of medicinal products intended for the treatment of pain EMA/CHMP/970057/2011 Page 4/29 1. Executive summary This Guideline is intended to provide guidance on the clinical development of new medicinal products for the treatment of pain. It replaces and updates the separate guidelines on neuropathic
Guideline on Cell based Medicinal Products
www.ema.europa.euas non-clinical and clinical development of cell-based medicinal products. This guideline is intended for products entering the MA procedure. However, the principles laid down in the guideline should be taken into consideration of applicants entering into the clinical trials.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE …
www.ema.europa.euaromatic substances etc., as well as the constituents of the outer covering of the medicinal products, e.g. gelatine capsules. Examples of different types of excipients are given in annex 1. Information on the excipients used in a medicinal product should be provided in part 3.2.P.1, 3.2.P.2, 3.2.P.4 and 3.2.A.3 of the dossier.
Guideline on the requirements to the chemical and ...
www.ema.europa.euCommittee for Medicinal Products for Human Use (CHMP)3 4 Guideline on the requirements to the chemical and 5 pharmaceutical quality documentation concerning 6 . investigational medicinal products in clinical trials . 7 . Draft . Draft agreed by Quality Working Party
Procedure under Article 5(3) of Regulation EC (No) 726 ...
www.ema.europa.euCommittee for Medicinal Products for Human Use (CHMP) Assessment report . Procedure under Article 5(3) of Regulation EC (No) 726/2004 . Nitrosamine impurities in human medicinal products . Procedure number: EMEA/H/A-5(3)/1490 . Note: Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted.
MHRA Guidance Note 8 - GOV.UK
assets.publishing.service.gov.ukmedicinal product 6 4. What is a medicinal product? 6 • Definition • Meaning of Disease 5. Advertising 7 • Regulations • Internet advertising 6. Deciding factors when determining the regulatory status of a product 8 7. Products that are not classified as medicines under the “functional” limb of the definition of a medicinal product 10
European Medicines Agency
www.ema.europa.euMEDICINAL PRODUCTS Objective The purpose of in-use stability testing is to establish - where applicable - a period of time during which a multidose product can be used whilst retaining quality within an accepted specification once the container is opened. Scope This guideline refers to medicinal products in multidose containers which - by ...
Good manufacturing practices guide for drug products
www.canada.caGood manufacturing practices ... Registration of Veterinary Medicinal Products (VICH) ... PIC/S Good Practices for Data Management and Integrity in Regulated GMP/GDP environments. Good manufacturing practices guide for drug products (GUI-0001) Page 12 of 156 8. ...
Module 1 - Administrative information application form
www.ema.europa.eudevelopment of medicinal products for rare diseases (orphan medicinal products) including market exclusivity, protocol assistance, eligibility for initiatives which support research and development, access to the centralised procedure and the …
Guidelines Detailed Commission guidelines on good
ec.europa.eu30 to investigational medicinal products, not specifically mentioned in these guidelines, are 31 Part I, Chapters 2, and 6, and Part III. 1 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1).
REG 174 INFORMATION FOR UK HEALTHCARE PROFESSIONALS
assets.publishing.service.gov.ukThis medicinal product contains 2 mg of alcohol (ethanol) per 0.5 ml dose. The small amount of alcohol in this medicinal product will not have any noticeable effects. 4.5 Interaction with other medicinal products and other forms of interaction No interaction studies have been performed.
A Guide to Defective Medicinal Products - GOV.UK
assets.publishing.service.gov.ukA Guide to Defective Medicinal Products A Guide for Patients, Healthcare Professionals, Manufacturers and ... • Advising and monitoring necessary actions by the responsible Licence Holder ... there are some additional questions which should be asked:
Committee for medicinal products for human use (CHMP)
www.ema.europa.euMay 20, 2021 · Committee for medicinal products for human use (CHMP) Minutes for the meeting on 17-20 May 2021 . Chair: Harald Enzmann – Vice-Chair: Bruno Sepodes . Disclaimers . Some of the information contained in this set of minutes is considered commercially confidential or sensitive and therefore not disclosed.
Guideline on Risk Assessment of Medicinal Products on …
www.ema.europa.euIntegration of animal and human data to assess the risks of the use of medicinal products during pregnancy is a critical task, which is aimed at reducing the induction of birth defects as far as possible. In this document the process of assessment of non-clinical, i.e. animal data is described, followed by guidance on the assessment of human data.
NfG on Maximum shelf-life for sterile products for human use
www.ema.europa.eucommittee for proprietary medicinal products (cpmp) note for guidance on maximum shelf-life for sterile products for human use after first opening or following reconstitution discussion in the quality working party (qwp) june 1995 october 1995 february 1996 transmission to …
Guideline on the use of the CTD format in the preparation ...
www.ema.europa.euCommittee on Herbal Medicinal Products (HMPC) Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products. 1. Final . Draft agreed by Organisational Matters Drafting Group . April 2007
Guideline on clinical development of fixed combination ...
www.ema.europa.euThe guideline primarily discusses the development of fixed combination medicinal products with two active substances. However, it is expected that the same principles would generally apply to fixed combination medicinal products containing three or more active substances.
Notes for applicants and holders of a Wholesale Dealer’s ...
assets.publishing.service.gov.uk2.1 Medicinal products are medicines for human use which are subject to the provisions of Directive 2001/83/EC. This includes unlicensed medicinal products commonly referred to as “specials”. 2.2 The Recitals of Directive 2001/83/EC advise that “It …
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ec.europa.euThis medicinal product is subject to additional monitoring. This will allow quick identification of ... (sterile concentrate). The vaccine is a white to off-white frozen dispersion (pH: 6.9 - 7.9). 4. CLINICAL PARTICULARS ... In order to improve the traceability of biological medicinal products, the name and the batch number .
Revision 7. 5
www.hsa.gov.sgmedical device delivers medicinal products or energy to the patient, whether they are intended to have a biological effect on the patient and local versus systemic effects, etc. A general medical device may also be incorporated with a medicinal product in an ancillary role to achieve its intended purpose (please refer to
ICH HARMONISED GUIDELINE
database.ich.orgRegarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of ... Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products.
COVID-19 Vaccine AstraZeneca
www.ema.europa.euPursuant to Article 8 of Regulation (EC) No. 141/2000 and Article 3 of Commission Regulation (EC) No 847/2000, the applicant did not submit a critical report addressing the possible similarity with authorised orphan medicinal products because there is no authorised orpha n medicinal product for a condition related to the proposed indication.
2021-09-08-Report on pharmaceutical aspects on impact of ...
www.ema.europa.euEach affected medicinal product will need an individual review and assessment, which will require investigation of alternatives, product reformulation, generation of new data related to manufacture, ... orphan medicines, low sales volume products, bee products, etc.).
Practical guidance for procedures related to Brexit for ...
www.ema.europa.euMedicinal Products for Human and Veterinary Use Annex 16: Certification by a Qualified Person and Batch Release). Also the site for batch control (where each batch undergoes full qualitative analysis, a quantitative analysis of at least all the active substances and other tests necessary to ensure the quality of the
GENERAL CONSIDERATIONS FOR CLINICAL TRIALS E8
database.ich.org3.1.2 Quality of Investigational Medicinal Products Formulations used in clinical trials should be well characterised, including information on bioavailability wherever feasible. The formulation should be appropriate for the stage of drug development. Ideally, the supply of a formulation
Pharmacovigilance Plan of the EU Regulatory Network for ...
www.ema.europa.euAn important requirement for the safety monitoring of all biological medicines in the EU (see GVP P.II: Biological medicinal products) is the need for product and batch traceability during clinical use. The traceability requirement covers the release by the manufacturer, the entire distribution chain and the actual vaccination.
VICH GL18(R): Impurities: Residual solvents in new ...
www.ema.europa.euTable 1) should be avoided in the production of active substances, excipients, or veterinary medicinal products unless their use can be strongly justified in a risk-benefit assessment. Some solvents associated with less severe toxicity (Class 2, Table 2) should be limited in order to protect target animals and human
HMPC monographs: Overview of recommendations for the …
www.ema.europa.euThe age range and use of herbal medicinal products, within this special population of patients, are frequently discussed by healthcare professionals. The purpose of this overview is to provide a summary of the information from the monographs for ease of reference.
Medicinal products in the European Union
www.europarl.europa.euThe first Community rules on medicinal products for human use date back 50 years. Beginning with Council Directive 65/65/EEC,6 which was introduced in the wake of the thalidomide disaster, the then-European Economic Community began developing structured legislation. The legal framework has since been continuously updated.
Guideline on the requirements for quality documentation ...
www.ema.europa.eu80 investigational medicinal product for a given clinical trial and not to provid e guidance on a Company's 81 . overall development strategy for a medicinal product. 82 Nevertheless, for all clinical development phases, it is the respo nsibility of the applicant (sponsor) to
IS IT A CLINICAL TRIAL OF A MEDICINAL PRODUCT?
assets.publishing.service.gov.uki Article 2 of The Human Medicines Regulations 2012 provides the definition of "medicinal product." ii Substance is any matter irrespective of origin e.g. human, animal, vegetable or chemical that is being administered to a human being. iii This does not include derivatives of human whole blood, human blood cells and human plasma that involve a manufacturing process.
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euThis medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT. Spikevax dispersion for injection
Guidance on the electronic submission of information on ...
www.ema.europa.eudevelopment medicinal product entity submitted to the XEVMPD by Organisation C is therefore owned in the XEVMPD by 'ORGC'. Proposed term: Term for which there is an application to the maintenance organisation, but the term is not yet approved or published. These terms are entered and maintained in the XEVMPD by sponsors
active substance, excipient and primary container ...
www.ema.europa.euoutside of the container sterile) is used to provide a specific protection to the medicinal product, the packaging process should be described, including a risk assessment, since it may affect the sterility of the finished product; for example, trapping moisture between the primary and secondary containers.
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