CHAPTER III

INSPECTIONS

Supervision by inspection
Article 17
1
By means of regular inspections as referred to in Article 63(4) of Regulation (EU) No 536/2014 the Member State shall ensure that holders of an authorisation as referred to in Article 61(1) of that Regulation comply with the principles of good manufacturing practice laid down in this Regulation and takes into account the guidelines referred in second subparagraph of Article 63(1) of Regulation (EU) No 536/2014.
2
Without prejudice to any arrangements which may have been concluded between the Union and third countries, a competent authority may require a third country manufacturer to submit to an inspection as referred to in Article 63(4) of Regulation (EU) No 536/2014 and this Regulation. This Regulation applies mutatis mutandis to such inspections in third countries.
3
Member States shall carry out inspections of third country manufacturers to ensure that investigational medicinal products imported into the Union are manufactured by applying quality standards at least equivalent to those laid down in the Union.
The Member States are not obliged to routinely inspect third country manufacturers of investigational medicinal products. The necessity of such inspections shall be based on an assessment of risk, but shall take place at least if the Member States have grounds for suspecting that the quality standards applied to the manufacture of the investigational medicinal products imported into the Union are lower than those laid down in this Regulation and in the guidelines referred to in the second subparagraph of Article 63(1) of Regulation (EU) No 536/2014.
4
Inspections may, if necessary, be unannounced.
5
Following an inspection, an inspection report shall be drawn up by the inspector. Before the report is adopted by competent authority, the manufacturer shall be afforded an opportunity to submit comments in relation to the findings of the report.
6
Where the findings of the final report show that the manufacturer complies with the good manufacturing practice for investigational medicinal products, the competent authority shall within a period of 90 days of the inspection issue a certificate of good manufacturing practice to the manufacturer.
7
The competent authority shall enter the certificate of good manufacturing practice which they issue into the Union database referred to in Article 111(6) of Directive 2001/83/EC of the European Parliament and of the Council .
8
Where the outcome of the inspection is that the manufacturer does not comply with good manufacturing practice for investigational medicinal products, the competent authority shall enter this information into the Union database referred to in Article 111(6) of Directive 2001/83/EC.
9
The competent authority shall, upon receipt of reasoned request, send the inspection reports referred to in paragraph 5 electronically to the competent authorities of other Member States or to the European Medicines Agency (‘the Agency’).
10
The competent authority shall enter the information relating to the authorisation referred to in Article 61(1) of Regulation (EU) No 536/2014 in the Union database referred to in Article 111(6) of Directive 2001/83/EC.

Cooperation and coordination of inspections
Article 18
The competent authorities shall cooperate with each other and with the Agency in relation to inspections. They shall share information with the Agency on both inspections planned and conducted.

Recognition of inspection conclusions
Article 19
1
The conclusions reached in the inspection report referred to in Article 17(5) shall be valid throughout the Union.
However, in exceptional cases, where a competent authority is unable, for reasons relating to public health, to recognise the conclusions reached following an inspection under Article 63(4) of Regulation (EU) No 536/2014, that competent authority shall forthwith inform the Commission and the Agency. The Agency shall inform the other competent authorities concerned.
2
When the Commission is informed in accordance with the second subparagraph of paragraph 1, it may, after consulting the competent authority which was unable to accept the report, request the inspector who performed the inspection to perform a new inspection. The inspector may be accompanied by two inspectors from other competent authorities which are not parties to the disagreement.

Empowerments of the inspectors
Article 20
1
The competent authority shall provide inspectors with suitable means of their identification.
2
Inspectors shall be empowered to:
a
enter and inspect the premises of the manufacturer and quality control laboratories having carried out checks pursuant to Article 10 for the manufacturer;
b
take samples, including for independent tests to be carried out by an Official Medicines Control Laboratory or a laboratory designated for that purpose by the Member State, and
c
examine any documents relating to the object of inspection, make copies of records or printed documents, print electronic records and take photographs of the premises and equipment of the manufacturer.

Competence and obligations of the inspectors
Article 21
1
The competent authority shall ensure that the inspectors possess adequate qualifications, experience and knowledge. In particular, the inspectors shall have the following:
a
experience and knowledge of the inspection process;
b
the ability to make professional judgements as to the compliance with the requirements of good manufacturing practice;
c
ability to apply the principles of quality risk management;
d
knowledge of current technologies relevant for inspections;
e
knowledge of the current technologies for the manufacture of the investigational medicinal products.
2
Information acquired as a result of inspections shall remain confidential.
3
The competent authorities shall ensure that inspectors receive the training necessary to maintain or improve their skills. Their training needs shall be assessed regularly by the persons appointed for that task.
4
The competent authority shall document the qualifications, training and experience of each inspector. Those records shall be kept up to date.

Quality system
Article 22
1
The competent authorities shall establish, implement and comply with a properly designed quality system for their inspectors. The quality system shall be updated as appropriate.
2
Each inspector shall be informed of the standard operating procedures and of his duties, responsibilities and ongoing training requirements. Those procedures shall be kept up to date.

Impartiality of inspectors
Article 23
The competent authority shall ensure that inspectors are free of any undue influence that could affect their impartiality and judgment.
Inspectors shall be independent, in particular, of:
1. the sponsor;
2. the management and personnel of the clinical trial site;
3. the investigators involved in the clinical trials where the investigational medicinal products manufactured by the inspected manufacturer are used;
4. the persons financing the clinical trial in which the investigational medicinal product is used;
5. the manufacturer.
Inspectors shall make an annual declaration of their financial interests in the parties inspected or other links to them. The competent authority shall take the declaration into consideration when assigning inspectors to specific inspections.

Access to premises
Article 24
The manufacturer shall allow inspectors access to his premises and documentation at all times.

Suspension or revocation of manufacturing authorisation
Article 25
If an inspection reveals that the holder of an authorisation as referred to in Article 61(1) of Regulation (EU) No 536/2014 fails to comply with good manufacturing practice as set out in Union law, the competent authority may, with regard to this manufacturer, suspend manufacture or imports from third countries of investigational medicinal products for human use, or suspend or revoke the authorisation for a category of preparations or all preparation.
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).