The notified body must carry out the appropriate examinations and tests in order to check the conformity of the appliance to the requirements of this Directive by examination and testing of every appliance, as specified in point 5.4, or by examination and testing of appliances on a statistical basis, as specified in point 5.5, at the choice of the manufacturer.

The manufacturer must allow the notified body access for inspection purposes to the locations of inspection, testing and storage and provide it with all necessary information, in particular:

The detailed guidelines on the documentation relating to the clinical trial, which shall constitute the master file on the trial, archiving, qualifications of inspectors and inspection procedures to verify compliance of the clinical trial in question with this Directive shall be adopted and revised in accordance with the procedure referred to in Article 21(2).

The CHMP reviewed the data submitted by Marketing Authorisation Holders from clinical trials, epidemiological studies, and spontaneous reporting of adverse drug reactions.

This Decision is a first step towards phasing out completely the obligation to test for hormones each consignment selected for physical checks, and the Decision will be reviewed on the basis of future test results.

Specify the various tasks of approved bodies depending on the required system of conformity attestation, including type and frequency of testing, of inspections and of surveillance, where relevant.

Data possibly or probably related to Renagel from these studies (299 patients) and from uncontrolled clinical trials (384 patients) are listed by frequency in the table below.

Table 1 contains very common (≥ 1/ 10) and common (≥ 1/ 100 to < 1/ 10) adverse reactions for which there is at least a reasonable suspicion of a causal relationship to INCRELEX treatment which occurred in clinical trials.

The manufacturer must operate an approved quality system for production, final inspection and testing as specified in section 3 and be subject to surveillance as specified in section 4.

The notified body must carry out the appropriate examinations and tests in order to check that the product complies with the requirements of the international instruments either by examination and testing of every product as specified in point 4 or by examination and testing of products on a statistical basis, as specified in point 5, at the choice of the manufacturer.

The manufacturer must allow the notified body access for inspection purposes to the inspection, testing and storage locations and provide it with all necessary information, in particular:

Tissues from ovine and caprine animals sent for laboratory testing pursuant to the provisions of Article 12(2) shall be subject to a histopathological examination as laid down in the latest version of the Manual, except where the material is autolysed.

The manufacturer must operate an approved quality system for design, manufacture, final-product inspection and testing as specified in point 3 and must be subject to surveillance as specified in point 4.

The following side effects listing is based on reports from clinical trials with Extavia (List 1) and from side effects reported on the marketed product (List 2).

The precise nature of the active substances, preparations, premixes and feedingstuffs examined, the reference number of the batches, the concentration of the active substance in premixtures and feedingstuffs, the testing conditions (temperature, humidity etc.) and also the dates and duration of testing, the adverse effects and further negative effects which occurred during testing shall be specified for each experiment.

The installer of a lift must apply an approved quality assurance system for final inspection of the lift and testing as specified in Section 3, and must be subject to surveillance as specified in Section 4.

The inspections including testing, as appropriate, required pursuant to Article 13 of Directive 2000/29/EC and in accordance with provisions laid down in the present Decision shall be made by the responsible official bodies, referred to in the said Directive;

The manufacturer of the safety components must allow the notified body access for inspection purposes to the design, manufacture, inspection and testing, and storage locations, and must provide it with all necessary information, in particular:

Overall survival outcome in the trials could not be satisfactorily explained by differences in the incidence of thrombosis and related complications between those given recombinant human M erythropoietin and those in the control group. A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.

One belt or restraint system is required for the inspection of the buckle and the strength tests on the buckle, the attachment mountings, the belt adjusting devices and, where necessary, the retractors."

It will meet twice a year and review all clinical trial, pharmaco- epidemiology and post marketing safety data obtained with pimecrolimus.

The manufacturer must apply an approved quality assurance system for final inspection of the safety component and testing as specified in Section 3, and must be subject to surveillance as specified in Section 4.

Clinical and Laboratory Standards Institute™ (CLSI), formerly NCCLS breakpoints are presented in the below table for MIC testing (mg/ l) or disc diffusion testing (zone diameter [ mm ]) using a 5-µg moxifloxacin disc.

Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials (comprising a total of 5253 patients, 3289 on duloxetine and 1964 on placebo).

Table 4, below provides the schedule followed for other dose modifications in the clinical trial in the treatment of patients with multiple myeloma receiving Caelyx and bortezomib combination therapy.

The installer of the lift must operate an approved quality assurance system for production, installation, final lift inspection and testing as specified in Section 3 and is subject to surveillance as specified in Section 4.

Clinical trial data and post-marketing data Table 3 presents adverse reactions by system organ class and by frequency category based on experience with glimepiride and other sulphonylureas.

4 The following table of undesirable effects (first year of treatment) is based on adverse events that occurred at a frequency of > 2 % and with an incidence ≥ 1 % above placebo in clinical trials of 1 and 2 years duration:

In controlled clinical trials, the following adverse reactions were reported in ≥ 1 % of patients with either concomitantly administered amlodipine plus lisinopril or with amlodipine and lisinopril monotherapies (see Table below):

Table 2 Adverse reactions very commonly and commonly reported in paediatric clinical trials  13 Very common (≥1/10) - Common (≥1/100, < 1/10) System Organ Class Infection and infestations

That person shall have at his disposal, or shall have access to, one or more quality control laboratories appropriately staffed and equipped to carry out the necessary examination and testing of the starting materials and packaging materials and the testing of intermediate and finished products.

The table below shows the efficacy data of the 48-week analyses on the recommended 600 mg dose of PREZISTA co-administered with 100 mg ritonavir b.i.d. from the pooled POWER 1 and POWER 2 trials as well as from the POWER 3 trial.

The adverse reactions listed in Table 4 are based on experience from clinical trials in adult naïve patients treated for 1 year and post-marketing use.

Table 1 lists adverse drug reactions (ADRs) reported for the 153 patients treated with Replagal in clinical trials, including 21 patients with history of endstage renal disease and 17 female patients.

The manufacturer must operate an approved quality assurance system for design, manufacture and final inspection of the safety components and testing as specified in Section 3 and must be subject to surveillance as specified in Section 4.

The person participating in a trial must consent to the scrutiny of personal information during inspection by competent authorities and properly authorised persons, provided that such personal information is treated as strictly confidential and is not made publicly available.

The installer of a lift must operate an approved quality assurance system for design, manufacture, assembly, installation and final inspection of the lifts and testing as specified in Section 3 and must be subject to surveillance as specified in Section 4.

The applicant will present the results from the planned Phase I/ II clinical trial (protocol under review at NCI) aimed at ruling out the possibility that secondary to proteasome inhibition bortezomib treatment may increase the risk of amyloidosis and/ or may have an adverse impact on its progression and organ manifestations.

Without prejudice to respectively Article 16(2) and 13c(8) of Directive 2000/29/EC, the results of the surveys provided for in the first paragraph and the results of the inspections and tests provided for in Article 2 shall be notified to the Commission and to the other Member States by 30 November 2004.

Following this request, the CHMP reviewed data on efficacy and the available data on the mentioned safety issue, including post-marketing reports, data from non-clinical studies, clinical trials and epidemiological studies.

The competent authority of the Member State concerned shall ensure, by means of repeated inspections, and if necessary unannounced inspections, and, where appropriate, by asking an Official Medicines Control Laboratory or a laboratory designated for that purpose to carry out tests on samples, that the legal requirements governing medicinal products are complied with.

in the case of investigational medicinal products manufactured in a third country, that each production batch has been manufactured and checked in accordance with standards of good manufacturing practice at least equivalent to those laid down in Commission Directive 91/356/EEC, in accordance with the product specification file, and that each production batch has been checked in accordance with the information notified pursuant to Article 9(2) of this Directive;

Until such time as the reproducibility of a method has been established by a collaborative trial, then for the purpose of preselection of candidate methods by desk review, it is necessary that data on repeatability, recovery and results obtained for certified reference materials are available.

The notified body must carry out the appropriate examinations and tests in order to check the conformity of the interoperability constituent with the type as described in the EC type-examination certificate and with the requirements of Directive 96/48/EC and of the TSI either by examination and testing of every interoperability constituent as specified in point 4 or by examination and testing of interoperability constituents on a statistical basis, as specified in point 5, at the choice of the manufacturer.

Diabetic Peripheral Neuropathic Pain Table 2 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials (comprising a total of 5253 patients, 3289 on duloxetine and 1964 on placebo).

The clinical trial subject's protection is safeguarded through risk assessment based on the results of toxicological experiments prior to any clinical trial, screening by ethics committees and Member States' competent authorities, and rules on the protection of personal data.

In addition to the ADRs described in Tables 4 and 5, and based on the above pooled analysis from clinical safety data from 7 clinical trials, encephalopathy was also associated with the use of Xeloda monotherapy with an incidence of less than 0.1 %.

Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials (comprising a total of 7976 patients, 4370 on duloxetine and 3606 on placebo) in SUI and other lower urinary tract disorders.

The notified body must carry out the appropriate examinations and tests in order to check the conformity of the subsystem with the type as described in the EC type-examination certificate and with the requirements of the TSI by examination and testing of every subsystem, manufactured as a serial product, as specified under point 4.

Adverse reactions, probably or possibly related to mycophenolate, reported in of patients treated with mycophenolate in the controlled clinical trials of renal (2 g data), cardiac and hepatic transplant patients are listed in the following table.