4. Where problems detected appear to be systemic in nature and may therefore entail a risk to other projects, the Responsible Authority shall ensure that a further examination is carried out, including additional controls where necessary, to establish the scale of such problems and whether the error rate is above the acceptable level.

4. Where problems detected appear to be systemic in nature and may therefore entail a risk to other projects, the Responsible Authority shall ensure that a further examination is carried out, including additional controls where necessary, to establish the scale of such problems and whether the error rate is above the acceptable level.

‘verification risk’ means the risk, being a function of inherent risk, control risk and detection risk, that the verifier expresses an inappropriate verification opinion when the operator’s or aircraft operator’s report is not free of material misstatements.

the Member State shall monitor the activities associated with the authorisation to ensure an acceptable level of safety and take appropriate action in case of identifying an increased risk or any safety concerns;

6. The mandate of the Pharmacovigilance Risk Assessment Committee shall cover all aspects of the risk management of the use of medicinal products for human use including the detection, assessment, minimisation and communication relating to the risk of adverse reactions, having due regard to the therapeutic effect of the medicinal product for human use, the design and evaluation of post-authorisation safety studies and pharmacovigilance audit.

(8) The verification mission carried out by the Commission in January/February 2000 revealed that despite some progress having been made, there are still serious problems as regards the implementation and the enforcement of the residue monitoring programme in place in the United States of America, and demonstrated that the programme does not entirely provide the guarantees concerning the protection of public health against risks from residues as required by the European Community; whereas the United States of America have agreed to take further action to rapidly remedy the deficiencies and have proposed on 8 February 2000 to contract out analytical wor ...[+++]k for the detection of certain substances to one or more approved laboratories capable of carrying out the required analyses and situated outside the United States of America; whereas a period of one month is considered as necessary for the United States of America to take the appropriate steps and make the relevant arrangements.