Article 17Supervision by inspection
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(1).
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.
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).