Table 1.
Summary table
| Resolution pharmacy preparation | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| BE | DK | F | UK | NL | PL | CZ | IE | IT | PT | RS | CH | Total | |
| Pharmaceutical equivalents (3.1) | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 5 |
| Preparing and dispensing pharmacy | |||||||||||||
| (regulations or contractual agreement; 3.2) | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 11 |
| Preparation authorisation or preparation licence for pharmacies (10.1) | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 11 |
| Company licence for pharmacy preparations (10.2) | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 12 |
| Preparation process (4) | |||||||||||||
| (Good manufacturing practice for high-risk preparations) | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 0 | 1 | 1 | 10 |
| Product dossier (5) | |||||||||||||
| (required for stock preparations) | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 8 |
| Marketing authorisation (6) | |||||||||||||
| (MA for pharmacy preparation) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Labelling (7) with mentioned elements | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 12 |
| Pharmacopoeia compliance (8) | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 12 |
| Transparency and safety (11) | |||||||||||||
| Reporting of quality and safety (11.1) | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 1 | 0 | 1 | 1 | 1 | 9 |
| Notification or announcement (11.2) | 0 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 6 |
| Inventory pharmacy preparations (11.3) | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 3 |
| Surveillance (11.5) | 0 | 1 | 1 | 1 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 7 |
| Distribution (13) | |||||||||||||
| Good distribution practice compliance | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 1 | 0 | 9 |
| Export and import of pharmacy preparations | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 12 |
1, complies with resolution; 0, does not comply with resolution.