TITLE XIII

GENERAL PROVISIONS
Article 127
1
At the request of the manufacturer, the exporter or the authorities of an importing third country, Member States shall certify that a manufacturer of medicinal products is in possession of the manufacturing authorization. When issuing such certificates Member States shall comply with the following conditions:
a
they shall have regard to the prevailing administrative arrangements of the World Health Organization;
b
for medicinal products intended for export which are already authorized on their territory, they shall supply the summary of the product characteristics as approved in accordance with Article 21.
2
When the manufacturer is not in possession of a marketing authorization he shall provide the authorities responsible for establishing the certificate referred to in paragraph 1, with a declaration explaining why no marketing authorization is available.