Updated on 29 February:
'Compliance with QRD template v10.4' section
The information contained in these documents is non-exhaustive. Companies should refer to all relevant European Union legislation and guidelines when drawing up applications. It is the company's responsibility to ensure that the product information complies with all such requirements.
The QRD template v10.4 was revised to delete 'United Kingdom (Northern Ireland)' from the list of local representatives in the package leaflet to comply with the Windsor Framework for labelling and packaging of medicines.
In addition, EMA has implemented the following minor changes:
For the implementation of the QRD template v10.4, please refer to the guidance below which includes questions and answers to stakeholders on the implications of Regulation (EU) 2023/1182 for centrally authorised medicinal products for human use (questions 5 and 9):
Questions and answers to stakeholders on the implications of Regulation (EU) 2023/1182 for centrally authorised medicinal products for human use
English (EN) (178.36 KB - PDF)
QRD product-information annotated template (English) version 10.4
English (EN) (507.15 KB - PDF)
QRD product-information annotated template (English) version 10.4 - highlighted
English (EN) (385.64 KB - PDF)
QRD product-information template version 10.4
English (EN) (64 KB - DOCX)
български (BG) (66.6 KB - DOCX)
español (ES) (63.49 KB - DOCX)
čeština (CS) (64.49 KB - DOCX)
dansk (DA) (64.81 KB - DOCX)
Deutsch (DE) (61.74 KB - DOCX)
eesti keel (ET) (51.22 KB - DOCX)
ελληνικά (EL) (67.74 KB - DOCX)
français (FR) (62.35 KB - DOCX)
hrvatski (HR) (67.99 KB - DOCX)
íslenska (IS) (58.64 KB - DOCX)
Gaeilge (GA) (57.24 KB - DOCX)
italiano (IT) (62.07 KB - DOCX)
latviešu valoda (LV) (59.56 KB - DOCX)
lietuvių kalba (LT) (50.47 KB - DOCX)
magyar (HU) (62.5 KB - DOCX)
Malti (MT) (71.5 KB - DOCX)
Nederlands (NL) (82.14 KB - DOCX)
norsk (NO) (59.27 KB - DOCX)
polski (PL) (63.1 KB - DOCX)
português (PT) (63.86 KB - DOCX)
română (RO) (61.98 KB - DOCX)
slovenčina (SK) (65.76 KB - DOCX)
slovenščina (SL) (60.04 KB - DOCX)
Suomi (FI) (75.38 KB - DOCX)
svenska (SV) (63.58 KB - DOCX)
QRD product-information template version 10.4 - highlighted
English (EN) (388.09 KB - PDF)
български (BG) (465.47 KB - PDF)
español (ES) (385.51 KB - PDF)
čeština (CS) (432.68 KB - PDF)
dansk (DA) (384.82 KB - PDF)
Deutsch (DE) (422.63 KB - PDF)
eesti keel (ET) (399.68 KB - PDF)
ελληνικά (EL) (409.69 KB - PDF)
français (FR) (394.17 KB - PDF)
hrvatski (HR) (394.9 KB - PDF)
íslenska (IS) (354.34 KB - PDF)
Gaeilge (GA) (404.75 KB - PDF)
italiano (IT) (390.65 KB - PDF)
latviešu valoda (LV) (382.73 KB - PDF)
lietuvių kalba (LT) (410.61 KB - PDF)
magyar (HU) (421.48 KB - PDF)
Malti (MT) (460 KB - PDF)
Nederlands (NL) (415.01 KB - PDF)
norsk (NO) (414.22 KB - PDF)
polski (PL) (452.79 KB - PDF)
português (PT) (407.16 KB - PDF)
română (RO) (416.15 KB - PDF)
slovenčina (SK) (471.76 KB - PDF)
slovenščina (SL) (405.62 KB - PDF)
Suomi (FI) (384.8 KB - PDF)
svenska (SV) (410.45 KB - PDF)
QRD annex A template
English (EN) (33.89 KB - DOCX)
български (BG) (19.05 KB - DOCX)
español (ES) (18.98 KB - DOCX)
čeština (CS) (18.8 KB - DOCX)
dansk (DA) (14.76 KB - DOCX)
Deutsch (DE) (18.7 KB - DOCX)
eesti keel (ET) (18.71 KB - DOCX)
ελληνικά (EL) (18.82 KB - DOCX)
français (FR) (18.8 KB - DOCX)
hrvatski (HR) (13.49 KB - DOCX)
íslenska (IS) (19.21 KB - DOCX)
Gaeilge (GA) (29.43 KB - DOCX)
italiano (IT) (19.3 KB - DOCX)
latviešu valoda (LV) (19.2 KB - DOCX)
lietuvių kalba (LT) (18.96 KB - DOCX)
magyar (HU) (18.64 KB - DOCX)
Malti (MT) (15.26 KB - DOCX)
Nederlands (NL) (18.59 KB - DOCX)
norsk (NO) (18.57 KB - DOCX)
polski (PL) (18.73 KB - DOCX)
português (PT) (18.64 KB - DOCX)
română (RO) (18.59 KB - DOCX)
slovenčina (SK) (18.65 KB - DOCX)
slovenščina (SL) (12 KB - DOCX)
Suomi (FI) (18.98 KB - DOCX)
svenska (SV) (19.39 KB - DOCX)
QRD annex related to the Article-127a template
English (EN) (19 KB - DOCX)
български (BG) (19.27 KB - DOCX)
español (ES) (19.13 KB - DOCX)
čeština (CS) (18.83 KB - DOCX)
dansk (DA) (19.34 KB - DOCX)
Deutsch (DE) (18.84 KB - DOCX)
eesti keel (ET) (18.84 KB - DOCX)
ελληνικά (EL) (19.07 KB - DOCX)
français (FR) (18.93 KB - DOCX)
hrvatski (HR) (19.44 KB - DOCX)
íslenska (IS) (19.03 KB - DOCX)
Gaeilge (GA) (23.04 KB - DOCX)
italiano (IT) (19.17 KB - DOCX)
latviešu valoda (LV) (19.13 KB - DOCX)
lietuvių kalba (LT) (19.14 KB - DOCX)
magyar (HU) (19.06 KB - DOCX)
Malti (MT) (19.14 KB - DOCX)
Nederlands (NL) (19.11 KB - DOCX)
norsk (NO) (19.06 KB - DOCX)
polski (PL) (19.2 KB - DOCX)
português (PT) (19.38 KB - DOCX)
română (RO) (19.48 KB - DOCX)
slovenčina (SK) (19.38 KB - DOCX)
slovenščina (SL) (19.29 KB - DOCX)
Suomi (FI) (18.76 KB - DOCX)
svenska (SV) (19.26 KB - DOCX)
QRD annex IV conditional positive template
English (EN) (14.86 KB - DOCX)
български (BG) (22.17 KB - DOCX)
español (ES) (32.38 KB - DOCX)
čeština (CS) (21.17 KB - DOCX)
dansk (DA) (22.29 KB - DOCX)
Deutsch (DE) (21.31 KB - DOCX)
eesti keel (ET) (19.92 KB - DOCX)
ελληνικά (EL) (21.89 KB - DOCX)
français (FR) (21.52 KB - DOCX)
hrvatski (HR) (21.77 KB - DOCX)
íslenska (IS) (16.72 KB - DOCX)
Gaeilge (GA) (18.82 KB - DOCX)
italiano (IT) (21.31 KB - DOCX)
latviešu valoda (LV) (20.33 KB - DOCX)
lietuvių kalba (LT) (22.17 KB - DOCX)
magyar (HU) (21.96 KB - DOCX)
Malti (MT) (19.4 KB - DOCX)
Nederlands (NL) (21.59 KB - DOCX)
norsk (NO) (16.19 KB - DOCX)
polski (PL) (20.6 KB - DOCX)
português (PT) (32.57 KB - DOCX)
română (RO) (21.62 KB - DOCX)
slovenčina (SK) (20.76 KB - DOCX)
slovenščina (SL) (19.93 KB - DOCX)
Suomi (FI) (18.3 KB - DOCX)
svenska (SV) (29.54 KB - DOCX)
QRD annex IV exceptional circumstances positive template
English (EN) (14.81 KB - DOCX)
български (BG) (19.53 KB - DOCX)
español (ES) (18.41 KB - DOCX)
čeština (CS) (16.82 KB - DOCX)
dansk (DA) (18.82 KB - DOCX)
Deutsch (DE) (18.61 KB - DOCX)
eesti keel (ET) (17.12 KB - DOCX)
ελληνικά (EL) (18.54 KB - DOCX)
français (FR) (18.6 KB - DOCX)
hrvatski (HR) (17.39 KB - DOCX)
íslenska (IS) (16.84 KB - DOCX)
Gaeilge (GA) (18.86 KB - DOCX)
italiano (IT) (18.36 KB - DOCX)
latviešu valoda (LV) (18.96 KB - DOCX)
lietuvių kalba (LT) (18.85 KB - DOCX)
magyar (HU) (18.59 KB - DOCX)
Malti (MT) (16.73 KB - DOCX)
Nederlands (NL) (16.66 KB - DOCX)
norsk (NO) (15.62 KB - DOCX)
polski (PL) (18.78 KB - DOCX)
português (PT) (18.75 KB - DOCX)
română (RO) (16.17 KB - DOCX)
slovenčina (SK) (19.28 KB - DOCX)
slovenščina (SL) (18.36 KB - DOCX)
Suomi (FI) (18.03 KB - DOCX)
svenska (SV) (18.06 KB - DOCX)
QRD annex IV standard positive template
English (EN) (21.17 KB - DOCX)
български (BG) (27.37 KB - DOCX)
español (ES) (28.08 KB - DOCX)
čeština (CS) (25.45 KB - DOCX)
dansk (DA) (25.87 KB - DOCX)
Deutsch (DE) (25.3 KB - DOCX)
eesti keel (ET) (23.98 KB - DOCX)
ελληνικά (EL) (25.87 KB - DOCX)
français (FR) (25.82 KB - DOCX)
hrvatski (HR) (24.35 KB - DOCX)
íslenska (IS) (23.97 KB - DOCX)
Gaeilge (GA) (18.78 KB - DOCX)
italiano (IT) (25.73 KB - DOCX)
latviešu valoda (LV) (45.5 KB - DOCX)
lietuvių kalba (LT) (25.81 KB - DOCX)
magyar (HU) (25.17 KB - DOCX)
Malti (MT) (25.52 KB - DOCX)
Nederlands (NL) (25.26 KB - DOCX)
norsk (NO) (22.44 KB - DOCX)
polski (PL) (26.52 KB - DOCX)
português (PT) (25.87 KB - DOCX)
română (RO) (22.72 KB - DOCX)
slovenčina (SK) (25.91 KB - DOCX)
slovenščina (SL) (25.11 KB - DOCX)
Suomi (FI) (25.03 KB - DOCX)
svenska (SV) (25.01 KB - DOCX)
QRD PSUR annex IV template
English (EN) (25.61 KB - DOCX)
български (BG) (28.17 KB - DOCX)
español (ES) (25.65 KB - DOCX)
čeština (CS) (27.35 KB - DOCX)
dansk (DA) (27.74 KB - DOCX)
Deutsch (DE) (28.34 KB - DOCX)
eesti keel (ET) (27.3 KB - DOCX)
ελληνικά (EL) (28.51 KB - DOCX)
français (FR) (24.99 KB - DOCX)
hrvatski (HR) (27.68 KB - DOCX)
íslenska (IS) (32.05 KB - DOCX)
Gaeilge (GA) (27.61 KB - DOCX)
italiano (IT) (34.26 KB - DOCX)
latviešu valoda (LV) (28.23 KB - DOCX)
lietuvių kalba (LT) (25.09 KB - DOCX)
magyar (HU) (27.62 KB - DOCX)
Malti (MT) (27.8 KB - DOCX)
Nederlands (NL) (28.97 KB - DOCX)
norsk (NO) (32.19 KB - DOCX)
polski (PL) (17.66 KB - DOCX)
português (PT) (27.74 KB - DOCX)
română (RO) (27.6 KB - DOCX)
slovenčina (SK) (27.98 KB - DOCX)
slovenščina (SL) (27.85 KB - DOCX)
Suomi (FI) (27.95 KB - DOCX)
svenska (SV) (27.78 KB - DOCX)
Implementation plan for the introduction of the safety features on the packaging of centrally authorised medicinal products for human use
Certain aspects of the implementation of the Falsified Medicines Directive (Directive 2011/62/EU) and the new delegated act on the safety features.
English (EN) (57.88 KB - PDF)
Policy on combined Summaries of Product Characteristics (SmPCs)
English (EN) (84.35 KB - PDF)
Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells
English (EN) (465.69 KB - PDF)
Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells highlighted
English (EN) (471.87 KB - PDF)
ATMP product information template version 1.1
English (EN) (75.28 KB - DOCX)
български (BG) (76.6 KB - DOCX)
español (ES) (56.26 KB - DOCX)
čeština (CS) (72.17 KB - DOCX)
dansk (DA) (68.65 KB - DOCX)
Deutsch (DE) (71.59 KB - DOCX)
eesti keel (ET) (68.65 KB - DOCX)
ελληνικά (EL) (74.87 KB - DOCX)
français (FR) (71.07 KB - DOCX)
hrvatski (HR) (69.8 KB - DOCX)
íslenska (IS) (74.72 KB - DOCX)
Gaeilge (GA) (69.98 KB - DOCX)
italiano (IT) (70.93 KB - DOCX)
latviešu valoda (LV) (71.34 KB - DOCX)
lietuvių kalba (LT) (72.74 KB - DOCX)
magyar (HU) (74.5 KB - DOCX)
Malti (MT) (70.77 KB - DOCX)
Nederlands (NL) (66.41 KB - DOCX)
norsk (NO) (78.6 KB - DOCX)
polski (PL) (72.84 KB - DOCX)
português (PT) (70.96 KB - DOCX)
română (RO) (70.27 KB - DOCX)
slovenčina (SK) (72.36 KB - DOCX)
slovenščina (SL) (63.83 KB - DOCX)
Suomi (FI) (69.33 KB - DOCX)
svenska (SV) (69.2 KB - DOCX)
ATMP product information template version 1.1 - highlighted
English (EN) (389.88 KB - PDF)
български (BG) (554.22 KB - PDF)
español (ES) (498.22 KB - PDF)
čeština (CS) (509.06 KB - PDF)
dansk (DA) (510.76 KB - PDF)
Deutsch (DE) (528.04 KB - PDF)
eesti keel (ET) (465.11 KB - PDF)
ελληνικά (EL) (540.74 KB - PDF)
français (FR) (512.14 KB - PDF)
hrvatski (HR) (506.62 KB - PDF)
íslenska (IS) (344.26 KB - PDF)
Gaeilge (GA) (504.32 KB - PDF)
italiano (IT) (480.52 KB - PDF)
latviešu valoda (LV) (527.91 KB - PDF)
lietuvių kalba (LT) (519.96 KB - PDF)
magyar (HU) (550.86 KB - PDF)
Malti (MT) (521.2 KB - PDF)
Nederlands (NL) (478.72 KB - PDF)
norsk (NO) (544.35 KB - PDF)
polski (PL) (509.24 KB - PDF)
português (PT) (477.56 KB - PDF)
română (RO) (522.3 KB - PDF)
slovenčina (SK) (502.72 KB - PDF)
slovenščina (SL) (508.21 KB - PDF)
Suomi (FI) (498.7 KB - PDF)
svenska (SV) (479.82 KB - PDF)
Mutual-recognition decentralised referral product information template (English) version 4.2
English (EN) (206.39 KB - PDF)
Mutual-recognition, decentralised and referral product-information template version 4.2
English (EN) (53.76 KB - DOCX)
български (BG) (63.4 KB - DOCX)
español (ES) (59.75 KB - DOCX)
čeština (CS) (55.27 KB - DOCX)
dansk (DA) (57.01 KB - DOCX)
Deutsch (DE) (50.13 KB - DOCX)
eesti keel (ET) (65.73 KB - DOCX)
ελληνικά (EL) (56.4 KB - DOCX)
français (FR) (50.62 KB - DOCX)
hrvatski (HR) (64.09 KB - DOCX)
íslenska (IS) (48.13 KB - DOCX)
Gaeilge (GA) (53 KB - DOCX)
italiano (IT) (51.63 KB - DOCX)
latviešu valoda (LV) (56.16 KB - DOCX)
lietuvių kalba (LT) (50.8 KB - DOCX)
magyar (HU) (65.23 KB - DOCX)
Malti (MT) (57.49 KB - DOCX)
Nederlands (NL) (55.4 KB - DOCX)
norsk (NO) (50.21 KB - DOCX)
polski (PL) (55.61 KB - DOCX)
português (PT) (49.8 KB - DOCX)
română (RO) (62.42 KB - DOCX)
slovenčina (SK) (56.63 KB - DOCX)
slovenščina (SL) (54.38 KB - DOCX)
Suomi (FI) (54.15 KB - DOCX)
svenska (SV) (66.28 KB - DOCX)
PSUSA nationally authorised products template
English (EN) (25.73 KB - DOCX)
български (BG) (28.86 KB - DOCX)
español (ES) (25.31 KB - DOCX)
čeština (CS) (26.77 KB - DOCX)
dansk (DA) (26.46 KB - DOCX)
Deutsch (DE) (27.3 KB - DOCX)
eesti keel (ET) (26.46 KB - DOCX)
ελληνικά (EL) (25.89 KB - DOCX)
français (FR) (24.79 KB - DOCX)
hrvatski (HR) (26.88 KB - DOCX)
íslenska (IS) (32.19 KB - DOCX)
Gaeilge (GA) (26.88 KB - DOCX)
italiano (IT) (27.13 KB - DOCX)
latviešu valoda (LV) (27.27 KB - DOCX)
lietuvių kalba (LT) (25.15 KB - DOCX)
magyar (HU) (26.81 KB - DOCX)
Malti (MT) (27.35 KB - DOCX)
Nederlands (NL) (27.24 KB - DOCX)
norsk (NO) (31.84 KB - DOCX)
polski (PL) (19.33 KB - DOCX)
português (PT) (27.09 KB - DOCX)
română (RO) (27.02 KB - DOCX)
slovenčina (SK) (27.28 KB - DOCX)
slovenščina (SL) (26.97 KB - DOCX)
Suomi (FI) (27.06 KB - DOCX)
svenska (SV) (26.96 KB - DOCX)
QRD Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics (Cover page)
English (EN) (113.94 KB - DOCX)
QRD Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics
English (EN) (19.06 KB - DOCX)
български (BG) (22.76 KB - DOCX)
español (ES) (19.31 KB - DOCX)
čeština (CS) (21.43 KB - DOCX)
dansk (DA) (20.2 KB - DOCX)
Deutsch (DE) (19.39 KB - DOCX)
eesti keel (ET) (22.41 KB - DOCX)
ελληνικά (EL) (23.22 KB - DOCX)
français (FR) (19.33 KB - DOCX)
hrvatski (HR) (21.49 KB - DOCX)
íslenska (IS) (25.72 KB - DOCX)
Gaeilge (GA) (19.49 KB - DOCX)
italiano (IT) (19.21 KB - DOCX)
latviešu valoda (LV) (19.17 KB - DOCX)
lietuvių kalba (LT) (20.16 KB - DOCX)
magyar (HU) (23.33 KB - DOCX)
Malti (MT) (19.87 KB - DOCX)
Nederlands (NL) (18.73 KB - DOCX)
norsk (NO) (19.41 KB - DOCX)
polski (PL) (16.39 KB - DOCX)
português (PT) (20.23 KB - DOCX)
română (RO) (18.7 KB - DOCX)
slovenčina (SK) (19.28 KB - DOCX)
slovenščina (SL) (23.92 KB - DOCX)
Suomi (FI) (21.08 KB - DOCX)
svenska (SV) (19.32 KB - DOCX)
QRD Appendix II - Medical Dictionary for Regulatory Activities terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics (Cover page)
English (EN) (114.72 KB - DOCX)
QRD Appendix II - Medical Dictionary for Regulatory Activities terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics
English (EN) (19.16 KB - DOCX)
български (BG) (20.35 KB - DOCX)
español (ES) (15.59 KB - DOCX)
čeština (CS) (20.12 KB - DOCX)
dansk (DA) (16.32 KB - DOCX)
Deutsch (DE) (19.93 KB - DOCX)
eesti keel (ET) (19.31 KB - DOCX)
ελληνικά (EL) (25.9 KB - DOCX)
français (FR) (20.01 KB - DOCX)
hrvatski (HR) (21.42 KB - DOCX)
íslenska (IS) (20.18 KB - DOCX)
Gaeilge (GA) (16.58 KB - DOCX)
italiano (IT) (19.93 KB - DOCX)
latviešu valoda (LV) (19.96 KB - DOCX)
lietuvių kalba (LT) (19.93 KB - DOCX)
magyar (HU) (19.5 KB - DOCX)
Malti (MT) (19.69 KB - DOCX)
Nederlands (NL) (19.71 KB - DOCX)
norsk (NO) (19.79 KB - DOCX)
polski (PL) (19.67 KB - DOCX)
português (PT) (16.68 KB - DOCX)
română (RO) (19.56 KB - DOCX)
slovenčina (SK) (20.63 KB - DOCX)
slovenščina (SL) (19.96 KB - DOCX)
Suomi (FI) (16.99 KB - DOCX)
svenska (SV) (26.57 KB - DOCX)
QRD Appendix III to the Quality Review of Documents templates for human medicinal products (Cover page)
English (EN) (114.48 KB - DOC)
QRD Appendix III to the Quality Review of Documents templates for human medicinal products
English (EN) (33 KB - DOC)
български (BG) (39 KB - DOC)
español (ES) (33.5 KB - DOC)
čeština (CS) (36.5 KB - DOC)
dansk (DA) (33 KB - DOC)
Deutsch (DE) (23.87 KB - DOCX)
eesti keel (ET) (34 KB - DOC)
ελληνικά (EL) (37 KB - DOC)
français (FR) (33.5 KB - DOC)
hrvatski (HR) (41.5 KB - DOC)
íslenska (IS) (33 KB - DOC)
Gaeilge (GA) (19.55 KB - DOCX)
italiano (IT) (34 KB - DOC)
latviešu valoda (LV) (31 KB - DOC)
lietuvių kalba (LT) (37 KB - DOC)
magyar (HU) (36 KB - DOC)
Malti (MT) (1022.5 KB - DOC)
Nederlands (NL) (35 KB - DOC)
norsk (NO) (33.5 KB - DOC)
polski (PL) (36.5 KB - DOC)
português (PT) (33.5 KB - DOC)
română (RO) (37.5 KB - DOC)
slovenčina (SK) (35.5 KB - DOC)
slovenščina (SL) (36.5 KB - DOC)
Suomi (FI) (33 KB - DOC)
svenska (SV) (33 KB - DOC)
QRD Appendix IV - Terms and abbreviations for batch number and expiry date to be used on the labelling of human medicinal products
English (EN) (139.15 KB - PDF)
QRD Appendix V - Adverse-drug-reaction reporting details
English (EN) (126.52 KB - DOCX)