GREECE Law and Practice Contributed by: Angela Livgieri and Danai Panopoulou, ALG Manousakis Law Firm
5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants Pharmaceuticals Manufacturing facilities must obtain a manufacturing license from EOF. According to Article 58 of the JM Decision, each manufacturing facility has to obtain a manufacturing license, which is granted under the fol- lowing conditions: • specify the medicinal products to be manufac- tured, as well as the place of manufacture; • ensure suitable and adequate premises, technical Furthermore, according to Article 9 of both Joint Min- isterial Decision DYG3a/7567/2008 and Joint Ministe- rial Decision YA D3 (a)/14709/2018, the manufacturer must ensure that manufacturing plants and equipment are sited, designed, constructed and maintained in such a way that they perform the functions for which they are intended. Additionally, they must be arranged and used in such a way as to minimise the risk of error and to permit effective maintenance in order to avoid direct and cross-contamination and any unde- sirable effect on product quality. EOF conducts on- site inspections to verify compliance with EU GMP standards. Medical Devices For medical devices, the decision issued by EOF 0−1016/22nd/15.12.2008 (Ministerial Decision 6209/2009) sets out the good manufacturing and con- trol rules to ensure the appropriate implementation of a quality system. As per Article 3 of the said decision, among others, the manufacturer of a medical device must have the following in place: • appropriately qualified and trained personnel; • adequate facilities and premises; • appropriate equipment and services; • appropriate materials, containers and labels; • approved procedures and instructions; • appropriate storage; and equipment, and control facilities; and • appoint at least one qualified person.
Medical Devices For medical devices, Article 11 (13) of the Joint Min- isterial Decision DY8d/130648/2009 and Article 59 of the MDR provide expedited pathways in specific cases where any competent authority may authorise, on a duly justified request, the placing of a specific device on the market, the use of which is in the inter- est of public health. EOF may grant temporary emer- gency use authorisation or national exemption before EU-wide approval. 4.2 Regulatory Reliance If a medicine has received a marketing authorisation from EMA (centralised procedure), it is automatically valid in all EU member states, including Greece. If another EU national competent authority grants an authorisation via the Mutual Recognition Procedure or Decentralised Procedure, EOF relies on that decision and does not reassess the application dossier. Non-EU reliance EOF may consider World Health Organisation (WHO) pre-qualified medicines in the event of global health emergencies. Pharmaceuticals EU-based reliance • EOF does not automatically accept non-EU approvals (eg, FDA, MHRA, etc); however, com- panies can submit foreign regulatory approvals as supportive data; • EOF may expedite the local review. Medical Devices If a device is already CE-certified by an EU Notified Body, EOF does not conduct an additional review. Registration with EOF is still required for local market entry. In general, as per Article 20 (1) of the MDR, medical devices that comply with its requirements bear the CE marking of conformity, which means they can be marketed in all member states. EOF does not automatically accept non-EU approvals (eg, FDA), but companies can submit foreign approv- als to strengthen applications.
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