Search results with tag "Authorisation"
Work Health and Safety Act 2012 - legislation.sa.gov.au
www.legislation.sa.gov.auPart 4—Authorisations. 40 Meaning of authorised. 41 Requirements for authorisation of workplaces. 42 Requirements for authorisation of plant or substance. 43 Requirements for authorisation of work. 44 Requirements for prescribed qualifications or experience.
Part 21 Overview - ICAO
www.icao.intEUROPEAN TECHNICAL STANDARD ORDER AUTHORISATIONS (ETSO) •Once authorised the articles shall be ETSO marked •The classification and approval of minor changes and repairs can be undertaken by the ETSO authorisation holder •A major change or repair requires a new application for an ETSO authorisation
European Medicines Agency pre-authorisation procedural ...
www.ema.europa.euauthorisation procedures and to reflect the implementation of the new European legislation. Revised topics will be marked by “New” or “Rev” upon publication. The EMA emphasises the importance of pre-submission meetings between applicants and the EMA/(Co-) Rapporteur. Pre-submission meetings (which should take place approximately 7 ...
EudraVigilance User Manual Marketing Authorisation …
www.ema.europa.euSection 6 updated to reflect the marketing authorisation status within the active substance grouping reports outputs . Section 8.3.3 updated to clarify the ‘hide columns’ functionality. Section 9.1 updated to clarify the use of the eRMR in relation to the frequency of monitoring . Section 9.3.1 created to describe the considerations
European Medicines Agency procedural advice for users of ...
www.ema.europa.euEligibility for duplicate marketing authorisations The eligibility request should also be submitted for duplicate generic/hybrid marketing authorisations. At the time of the request for eligibility, the name proposed by the applicant for the duplicate should be different from the name of the original generic/hybrid medicinal product. References
Guidelines for Control of Cosmetic Products in Malaysia
www.npra.gov.myLetter of Authorisation (LOA) / Letter of Declaration A Letter of Authorisation (LOA) is issued by the product owner including the list of products or brands authorising the CNH to notify the products with the NPRA and be responsible for all matters pertaining to product notification if the CNH is not the product owner.
European Medicines Agency post-authorisation procedural ...
www.ema.europa.euEuropean Medicines Agency post-authorisation procedural advice for users of the centralised procedure EMEA-H-19984/03 Page 2/299 . Questions and answers are being updated continuously and will be marked by “NEW” or “Rev.” with
Guideline on the environmental risk assessment of ...
www.ema.europa.eu59 outlines general considerations and the recommended step- wise procedure of assessment. The general ... 88 An ERA is not required for renewals of marketing authorisations or Type IA/IB variations. For further 89 . details, please refer to the Agency’s pre- authorisation guidance, Q …
Driver Authorisation Renewal Application
www.support.transport.qld.gov.auTransport Operations (Passenger Transport) Regulation 2018 This form is to be used if you are applying to renew your driver authorisation (DA) to drive a public passenger vehicle. All relevant questions must be answered or the application will not be processed and will be returned to you for completion. Driver details
Close an account - TSB
www.tsb.co.ukAccount Maintenance Services TSB PLC, Ariel House,2138 Coventry Road, Sheldon, Birmingham, B26 3JW. The branch must complete the back of this request before the account is closed. Close an account. Your request to Your personal details Details of account(s) to be closed Cheque book and debit card/bankers card details Authorisation and disposal ...
IIFL Account Opening Form NON - IndiaInfoline
content.indiainfoline.comNov 19, 2003 · Authorisation Letter A. Availing Mutual Fund Service System (MFSS) facility/ BSE StAR MUTUAL FUND (hereinafter jointly referred to “Mutual Fund Transaction ... Nomination in respect of the beneficiary owner account stands rescinded upon closure of the beneficiary owner account.Similarly ...
Clinical trial authorisation framework in Europe - overview
www.ema.europa.euEthics committee (Feb. 2006) CT Safety reporting (Apr. 2006) GMP directive. Oct. 2003. GCP directive. April 2005. Guidance on IMP and other MP used in CTs
ORIGINAL EQUIPMENT MANUFACTURER(OEM)’S …
sbi.co.inORIGINAL EQUIPMENT MANUFACTURER(OEM)’S AUTHORISATION FORM (in Original Letter Head of OEM) (To be mandatorily submitted along with the Technical Bid document) To Senior Vice President SBI Infra Management Solutions Pvt. Ltd., 3rd Floor, Local Head Office, State Bank of India
Guideline on good pharmacovigilance practices (GVP)
www.ema.europa.euEuropean Medicines Agency www.ema.europa.eu Heads of Medicines Agencies www.hma.eu The European Medicines Agency is ... Adverse reaction data collected in the EudraVigilance Post-Authorisation Module ..... 44 VI.C.6.2.1.2. Adverse reaction data collected in the EudraVigilance Clinical Trial Module .... 45 VI.C.6.2.2. ...
Guidelines For The Administration Of Medicines to Adults ...
foi.nhsgrampian.orgauthorise the unlicensed use of medicines. Authorisation by the prescriber (ideally in writing) should be obtained prior to any adjustment in how an oral dosage is administered. General recommendations for drug administration via enteral tubes: Use enteral syringes at all times, not injection syringes.
1. Administration of Medicines
hgs.uhb.nhs.uk1. Administration of Medicines 1.1. Medicines Administration 1.1.1. General Medicines administration must only be undertaken: on the authorisation of a prescriber (PICS prescription or other approved prescription (see list in Appendix C) in accordance with a PGD approved for use within the Trust or
Administration of medications in schools procedure
ppr.qed.qld.gov.auAdministration of medication at school record sheet (emergency medication) or prescribing health practitioner’s written advice ... ensure medication to be administered has medical authorisation e.g. the original container is labelled
MEDICINE ADMINISTRATION VIA THE ENTERAL FEEDING …
services.nhslothian.scotAdministration of medicine via an enteral feeding tube generally falls outside a medicine product license/marketing authorisation Check with a pharmacist regarding medicine administration via an enteral feeding tube. To minimise tube blockage or drug-nutrient interactions.
PHARMACOVIGILANCE GLOSSARY Section 1 Definitions of ...
www.emwa.orgauthorisation, medication errors can lead to ADRs. The EMA guidance “Good practice guide on recording, coding, reporting and assessment of medication errors” (EMA/762563/2014, 23 October 2015) points out that medication errors may occur at all stages of the drug treatment process (e.g. prescribing, storage, dispensing,
Medication Policy and Procedures
www.welcomeindependentliving.co.ukThe Manager will ensure procedure is followed checking that the Medication Authorisation has been gained and the appropriate form signed and placed on the Customers records. The Manager is responsible for the MAR charts to be ... for the administration of medication and make arrangements for the safe . 7 handling of medication and provide ...
Trailer registration numbers and number plates
assets.publishing.service.gov.ukVehicle Licensing Agency (DVLA). This applies to: • all commercial use trailers that weigh over 750kg ... plate authorisation certificate to the RNPS. We ... black characters (the letter and numbers) on a white background. The characters and the surface of the
Regulatory Toxicology - Society of Toxicology
www.toxicology.orgOverview/Objectives ... Duration of Repeat Dose Toxicology Studies Depends on Clinical Trial Duration . ICH M3 (R2) Non -Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorisation for Pharmaceuticals (2009) Industrial chemicals: Driven by production volume/import tonnage (ECHA 2014)
Mental Health Act 2009 - legislation.sa.gov.au
www.legislation.sa.gov.au102 Offences relating to authorisations and orders. 103 Medical practitioners or health professionals not to act in respect of relatives. 104 Removing inpatients from treatment centres. 106 Confidentiality and disclosure of information. 107 …
Guideline on good pharmacovigilance practice (GVP)s
www.ema.europa.euUse outside the marketing authorisation includes off -label use, overdose, misuse, abuse and medication errors (see GVP Annex I), which are all important aspects related to the pattern of utilisation of medicines in the paediatric population (see P.IV.A.1.4.).
Introduction to ISO Identification of Medicinal Products ...
www.ema.europa.euWhilst the initial driver for the development of these standards was pharmacovigilance, as the project ... of an application is available in a standard and well-understood format. ... for example, information provided as part of authorisation procedures can be used as the pharmacovigilance submission; Product and substance information can be ...
Variations in eCTD format Q&A document - Europa
esubmission.ema.europa.euincluding different types of variations for a single marketing authorisation, the highest variation(s) that are used to qualify the group submissions are withdrawn? A 3.7: The Procedure number will not change. There are no other consequences for eCTD than identified above under rejection/withdrawal (see A 3.5 and A 3.6).
FLOW CHART OF THE DECENTRALISED PROCEDURE 1. Issue 2 ...
www.hma.eustages taking into account: - Harmonisation of originator SPCs - The quality of the file - The assessment report It is possible to end the procedure at Day 105 if consensus is reached, at Day 120, at Day 150 and at Day 210 (followed in each case by 30 days for the national step – text translations/granting of marketing authorisation).
PSUR Repository user guide for MAH submissions - Europa
esubmission.ema.europa.euprocedures. PSUR submission for product lifecycle maintained using Electronic Common Technical Document (eCTD) format including examples of workaround solutions and constraints There are a range of possible scenarios in which eCTD format could be used spanning across different marketing authorisation types.
Timetable: Initial (Full) Marketing Authorisation ...
www.ema.europa.eu(¬) This timetable is not applicable to Advanced Therapy Medicinal Products (ATMPs); for these the applicant should refer to the timetable for initial …
Completing the application to cancel your firm’s …
www.fca.org.uksince authorisation then we require an auditor’s report that states whether anything has come to the auditor's attention that causes them to believe that the firm held client money and/or assets during the period covered. The auditor’s report . must. be in …
22 December 2021
www.fca.org.ukThis letter is for firms who gave pension transfer advice to British Steel Pension Scheme members between 1 March 2017 to 31 March 2018 (‘the relevant period’). ... a new authorisation or adding permissions. Applications from firms that have not adequately addressed the issue of liabilities will be subject to additional scrutiny.
Parent's Consent Form for a School-Aged or Young Child
s3.treasury.qld.gov.auIf a child does not have a parent or guardian the child may seek authorisation to work by applying for a Special Circumstances Certificate. School-Aged Child A school-aged child is a child who is under 16 years and required to be enrolled at a school. A child who is below the age of 16 years is not a school-aged child if the child has completed ...
List of ETSO Authorisations - European Union Aviation ...
www.easa.europa.euApproval Number Date of last issueDescription Partnumber(s) ETSO Standard(s) DDP Reference EASA.IM.21O.10030308 10.06.10 Air Cargo Net 1519-4500-() C90C 2 9 DDP ETSO-C90C EASA.IM.21O.10046587 01.10.13 Cargo Restraint Strap Assemblies 1519-172-( )-( ) C172 1 1 1519-172-SERIES ACR ELECTRONICS, Inc. - 5757 RAVENSWOOD ROAD 33312-6645 …
IVDR Documentation Submissions - BSI Group
www.bsigroup.comRegulatory Guidanc e Organisations.....25 B3. Specific Topic Guidance .....25 . IVDR Documentatoi n Submsisoi ns – Revision 3, May 2020 Page 3 of 27 ... 2.1 Authorisation for Work to be Conducted A signed approved quote will be required before work can commence. If this is not already in place,
Nitrosamines EMEA-H-A5(3)-1490 - Information on ...
www.ema.europa.euInformation on nitrosamines for marketing authorisation holders EMA/189634/2019 Page 2/5 form or are carried over during production, the impurities should normally be controlled and removed during the manufacturing process. Therefore, despite …
Macquarie withdrawal form
www.macquarie.com.auYour account details – Funds will be debited from this account Account number: Account name: ... please use this form only for account closure. To transfer funds between your Accelerator and CMA, please visit Macquarie Online Banking and the Macquarie Mobile Banking app. ... • authorisation of the transaction needs to be verified
Safety Data Sheets for Hazardous Chemicals
www.hsa.iebecomes available or when an authorisation is granted or refused, or a relevant restriction is imposed under REACH, provided to everyone who has received the chemical during the previous 12 months upon update or revision, and dated and the pages numbered. Safety Data Sheets for Hazardous Chemicals Information Sheet April 2021
LL1 APPLICATION FOR AANSOEK OM LEARNER’S LICENCE ...
www.westerncape.gov.za(Authorisation by Examiner for Driving Licences) (Magtiging deur Toetsbeampte vir Bestuurslisensies) Serial number of theory test (form TLL) and date of test and en 2:0 : : : Reeksnommer van teorietoets (vorm TLL) en datum van toets Y/J M D Code of learner’s licence by Examiner for Driving Licences - Kode van leerlinglisensie deur
Authority for RNs and Midwives - Ministry of Health
www.health.nsw.gov.auPrevious authorisation to supply poisons and restricted substances dated 19 February 2021 published in the New South Wales Government Gazette 86 on 5 March 2021 is hereby revoked. Validity This authority commences on the day it is signed and dated, and expires on the date 15 February 2024, or otherwise on a date that this authority is revoked.
EudraVigilance - EVWEB User Manual
www.ema.europa.euEudraVigilance also provides advice on the measures to ensure the safe and ... (i.e. the pre- and post-authorisation phase). These processes include clinical studies, reports of spontaneous adverse reactions, events, regulatory submissions and regulated product information.
AUTHORISATION FOR COLLECTION OF IDENTITY …
www.immd.gov.hk(a) to process your authorisation to a representative for the collection of your identity card / travel document on your behalf; (b) to administer / enforce relevant provisions of the Hong Kong Special Administrative Region Passports Ordinance (Chapter 539), the Immigration Ordinance
AUTHORISATION FOR CLOSURE OF ACCOUNT - DBS
www.dbs.com.sg2. The Bank reserves its right to refuse to accept any application without assigning any reason. 3. In the event that the Cashier’s Order purchased is lost, stolen or destroyed, the Applicant may request for payment on the Cashier’s Order to the stopped, and for a replacement Cashier’s Order to be issued or a refund of the amount of the
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