Competent authority

Sometimes a compromise in the quality of the inputs (perhaps due to non-availability of a particular component to the required specification) may be necessory to avoid a production delay. Similar constraints in the design or process may also make it necessary to have a deviation in design, without undermining the quality requirements. The ISO emphasizes that, for such deviations, written authorization from a competent authority, and preferably also the written consent of the customer, is essential before implementing sueh a change. This will be for a specific period and for a specific number of items. 

Consult experts including competent authorities (in UK the HSE must be given 28 days prior notice of specified work with ionizing radiation). 

Laboratories wishing to claim GLP compliance are nonually registered with Competent Authorities who issue statements of compliance following successful periodic inspections of the premises to monitor compliance with the relevant legislation. In the UK compliance with the Good Laboratory Practice Regulations 1999 is audited by the Medicines Control Agency. 

Ensure tanks are certified by competent authority/approved person. 

The Council of the American Chemical Society, acting through its Committee on National Policy, appointed editors and associates to select authors of competent authority in their respective fields and to consider critically the manuscripts submitted. The first Monograph appeared in 1921 Since 1944 the Scientific and Technological Monographs have been combined in the Scries... 

The work of commissioning must be under the control of a single competent authority, whether it be the main contractor, a consultant or the user. Since this authority must accept the installation, it should be so stated in the original contract. Other specialists may... 

Commission Regulation (EC) No. 1084/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State... 

Executive responsibility for the administration of regulations at national level is divested in dedicated agencies. Although distinct from government departments, the Ministers of Health are the usual political masters of these national Competent Authorities. Eor example, the authority in Ireland is known as the Irish Medicines Board (IMB) and it covers both drugs and devices. Similar to the EMEA, the authorities are scientific and technical in orientation and are guided by various advisory panels. Their main tasks include ... 

Before a clinical trial can commence, it is necessary to submit a Clinical Trial Application (CTA) to the Competent Authority of each Member State, where it is... 

The Competent Authorities are allowed a maximum of 60 days to review the data, or 90 days in the case of trials involving medicinal products for gene therapy, somatic cell therapy (including xenogeneic cell therapy), and all medicinal products containing genetically modified organisms. Such trials require written authorisation from the Competent Authority as distinct from other types of product where the authorities may just notify the sponsor of the acceptability (no-objection) of the application. If issues are raised, the sponsor may amend the application once, with a consequent extension to the allowed review period. 

Applications to the Ethics Committee should be made using the same application form as used for the Competent Authority. Most of the data submitted to the Competent Authority will also need to be included in the application to the Ethics Committee, although the IMPD is usually not required. Similar to the Competent Authority, the Ethics Committee is allowed 60 days to deliver an opinion (90 days for advanced therapy products), having given particular attention to the following ... 

List of Competent Authorities within the Community to which the application has been submitted and details of decisions... 

In the case of multi-centre, multi-state trials a single opinion should be delivered from each Member State. Only vhen a positive response has been obtained from an Ethics Committee and a Competent Authority can a trial commence. 

During the course of its conduct, the sponsor may need to amend a clinical trial, as a consequence of the emergence of new information. If the amendments are deemed to be substantial, in that they may impact on the safety of trial subjects, or change the interpretation of the scientific documents in support of the conduct of the trial, or are otherwise significant, the sponsor shall notify the Competent Authority and the Ethics Committee, using a Trial Amendment Form. The Ethics Committee are permitted 35 days to approve the amendment. 

If the events are classified as Suspected Unexpected Serious Adverse Reactions (SUSARs) that are fatal or life-threatening, the sponsor must then report them to the Ethics Committee and the Competent Authority within 7 days. Other SUSARs must be reported within 15 days. The sponsor must also inform all other investigators involved in the trial. The Competent Authority is required to enter the information... 

In addition to the expedited reporting described above, sponsors shall submit, once a year throughout the clinical trial, or on request, a safety report to the Competent Authority and the Ethics Committee. This should cover SUSARs, other serious adverse reactions, and an analysis of the subjects safety during the course of the trial. 

The Competent Authorities are obliged to appoint Inspectors for checking that all activities associated with clinical trials are conducted in compliance with the regulations. The inspectors can inspect any sites concerned with the clinical trial, particularly the trial site (GCP), the manufacturing site of the investigational medicinal product (GMP), any laboratory used for analyses in the clinical trial (GLP), and/or the sponsor s premises. 

The sponsor must inform the Competent Authority and the Ethics Committee of the end of a trial within 90 days of its completion. The sponsor will then prepare a trial report, where the data are analysed and assessed, with conclusions presented. 

It is worthwhile to note that, in the US, where the applicant will just be dealing with a single authority, there is no need to re-submit data that was previously submitted as part of an IN D application to conduct clinical trials. Instead, the applicant can cross-reference the IND file. This does not apply in Europe, because clinical trial applications will have been submitted to individual Competent Authorities, whereas marketing authorisation applications are usually submitted either centrally to the European Medicines Agency (EMEA) or collectively to a number of Competent Authorities. Thus, the files need to be self-supporting. 

Outside of the products that come within the scope of Community Authorisations, all other products can only be licensed via application to the Competent Authorities of individual Member States. However, through the use of either decentralised or mutual recognition procedures it is possible to obtain authorisations on the basis of a dossier assessment conducted by a single Member State. 

The decentralised procedure can be used in cases where the product has never been authorised in any of the Member States, and the applicant wishes to obtain a license in a number of states simultaneously. The applicant must submit applications with the complete dossier to the Competent Authorities of each of the Member States where authorisation is desired. A single Member State should be chosen as the reference state to undertake the scientific assessment ofthe complete dossier, while the other states are designated as concerned states. The review process has many parallels vhth the centralised procedure, in that similar time lines exist, the reference State plays the role ofthe rapporteur, and the concerned States replace the CHMP. Once all States have validated that the dossiers are complete, the reference State is allowed 70 days to review the dossier and prepare a preliminary assessment report, which is circulated to the concerned Member States and the applicant. Comments from the concerned Member States and applicant responses are collected so that by day 120 the reference State may issue a draft assessment report together vhth draft SPC, label and leaflet texts. The clock may be stopped until requested responses from the applicant are received. The application then enters the second step in the assessment process, during which all the concerned Member States consider the... 

Before initiating a clinical investigation, the manufacturer (or his/her authorised representative) must prepare a statement containing the information outlined in Figure 10.2, and notify the relevant Competent Authorities of the proposed study. The manufacturer must also keep available for inspection by the Competent Authorities the information outlined in Figure 10.3. Unlike for clinical trials, a standard application form has not been developed. Instead, appropriate application forms are... 

All adverse events that cause or have the potential to cause death or serious injury must be reported to the Competent Authorities of the Member States where the investigations are being conducted. 

Figure 10.3 Information relating to clinical investigations that must be maintained available to Competent Authorities for inspection.

The manufacturer, or his /her authorised representative, must inform the Competent Authority of ... 

In the case of IVDs that require the involvement of a Notified Body, data on performance characteristics, the results of performance evaluation and device certificates issued by the Notified Body must be included in the submission. The Competent Authorities are responsible for entering the following information in a European medical device databank, EUDAMED ... 

The manufacturer must also notify the Competent Authority of any significant modifications to devices, or discontinuance in the market. 

Pharmaceutical manufacturing activities as licensed by the Competent Authorities. 

As described previously, persons responsible for placing medical devices on the EU market are only required to notify the Competent Authority in the state where... 

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