The IASC Board agreed in principle, in April 1997, to undertake a review of the way in which performance is measured and reported.

Prior to administration, the ORENCIA solution should be inspected visually for particulate matter and discolouration.

Whereas the authorization conditions must be periodically reviewed and if necessary updated;

Reconstituted solutions should be visually inspected for particulate matter or discolouration.

Parenteral drug products should be inspected visually for particulate matter and discolouration 24

Before using TRACTOCILE, the solution should be examined to ensure it is clear and free from particles.

After 24 h incubation at 37 °C +- 1 °C, the plates must be examined for Enterobacteriaceae growth.

Instruct the patient that any extra needles and swabs that remain after the final dose has been taken from the pen, must be discarded appropriately and safely. t uc

Patients with a history of an intracranial lesion should be examined frequently for progression or recurrence of the lesion.

Prior to administration, the Soliris solution should be visually inspected for particulate matter and discolouration.

If the compliance of the subsystem with the requirements of the TSI is based on more than one quality system, it has to examine in particular,

The solution should be visually inspected for particulate matter and discolouration prior to administration.

As for all parenteral products, ampoules of Pedea should be visually inspected for particulate matter and the integrity of the container prior to use.

Patients should be evaluated after 6 weeks and, if no effect is seen, consideration should be given to stopping treatment.

The notified body must examine the application concerning the validity of the typeexamination and the typeexamination certificate.

After a 4-week treatment-free period, clearance of AKs should be assessed.

ge As with all parenteral medicinal products, prior to administration inspect Viraferon, solution for injection, visually for particulate matter and discolouration.

Differential white blood cell counts should also be performed prior to each dose of cidofovir (see section 4.8).

Where incision of the above lymph nodes is obligatory, they must be systematically subjected to multiple incisions and a visual inspection.

Article 7 - Markets defined under the former regulatory framework, where obligations should be reviewed.

Existing practices and procedures will have to be reviewed and changed if they do not provide an adequate level of security.

Any patient with the onset of a limp or complaint of hip or knee pain should be evaluated.

The substance should be examined in a bacteriological (reverse mutation) test with and without metabolic activation.

In that case, at least 10 % of each collection of semen (with a minimum of five straws) must be treated.

Parenteral solutions should be inspected visually for particulates and discoloration prior to administration.

Visually inspect parenteral medicinal products for particulate matter or discolouration prior to administration.

Complete blood counts should be performed at the beginning of each treatment cycle for patients receiving treatment with SUTENT.

Viani Evohaler should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.

Where there is reason to doubt that the applicant's vision is adequate, he shall be examined by a competend medical authority.

All patients with PWS should be evaluated for sleep apnoea and monitored if sleep apnoea is suspected.

The Agency therefore needs to revisit its policy on access to documents and related copyright issues.

Stability and solidity must be checked appropriately and especially after any change in the heigt or depth of the workstation.

In that case, each consignment must pass an examination by inoculation into a live animal and/or virus isolation test.

Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.

Parenteral solutions must be inspected visually for particulate matter and discolouration prior to administration.

Immediately before administration, the solution should be inspected visually for undissolved particulate matter and discoloration.

Seretide Evohaler should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.

If the filters cannot be examined repeat the entire digestion process with extended digestion time according to point 1.

If this attribute is used the precise indication of the place in coded form where the goods can be examined is necessary.

If any of these symptoms are reported, a detailed muscle examination should be performed in order to evaluate muscle function.

If any patient develops symptoms suggesting hepatic dysfunction liver function tests should be performed.

Each certificate which accompanies a consignment of live animals originating in a third country must be inspected in order to confirm:

the bronchial and mediastinal lymph nodes (Lnn. bifurcationes, eparteriales and mediastinales) must be incised and examined.

The notified body must examine the alterations and inform the applicant whether the EC type-examination certificate remains valid (1).

A meridian section shall be made in the base of the cylinder and polished for examination at a magnification of between 5 and 10. The cylinder must be regarded as defective if the presence of fissures is detected.

After 2-4 weeks of treatment, patients should be re-assessed in order to evaluate the benefit and tolerability of the therapy.

The SPC for melphalan should be consulted for information on the interactions of other medicinal products with melphalan.

The formal protocols for the sentinel monitoring surveillance should be reviewed by the CHMP.

The headlamp shall be operated for 12 hours as described in 1.1.1 and checked as prescribed in 1.1.2.

Patients developing dyspnoea while treated with EXUBERA should be examined for pulmonary or