Definition of characteristics of medicinal products available without medical prescription
The criteria for the classification of human medicinal products are defined in Section 39 of Act No. 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (“Act on Pharmaceuticals"), as amended. Medicinal products may be supplied without a medical prescription unless they meet the criteria for prescription only supply (paragraph 2) or for a supply without a medical prescription subject to restrictions (paragraph 3). The requirements for the documentation which shall be provided in the marketing authorisation application or a variation application for a medicinal product proposed for a supply without a medical prescription, are defined in Annex 6 of Decree No. 228/2008 Coll., on Marketing Authorisation of Medicinal Products, as amenden (“Marketing Authorisation Decree").
In compliance with Section 39 paragraph 6 of the Act on Pharmaceuticals, the Institute has defined thecharacteristics of medicinal products designed for supply without a medical prescription (see table below). If a medicinal product meets these characteristics, its legal status does not have to be assessed individually. This approach is applicable to both medicinal products where the marketing authorisation procedure is pending, and authorisation products where an application for a variation of marketing authorisation must be submitted to change the legal status. The characteristics of the medicinal products are defined with regard to the active substance, its strength, maximum single dose, maximum daily dose, and the maximum pack size related to the content of active substance. In addition, indications for the products which may be supplied without a medical prescription have been defined. The indications are general only, and the indications specified by the individual authorised products do not have to necessarily match these indications word for word.
If a medicinal product meets the defined characteristics, a comprehensive documentation required by Annex 6 of the Marketing Authorisation Decree does not have to be provided in the submitted application. The following documentation is sufficient in this case:
- Application for a variation of marketing authorisation, type II
- Proof of payment of the administrative fee and the reimbursement of costs (UST-29)
- Draft package leaflet, appropriately modified to meet the requirements for the product’s dupply without a medical prescription (see Annex 6 of the Marketing Authorisation Decree, Guideline REG-41)
- Draft text on the packaging.
Fot the applications for change of legal status of products that do not meet the criteria below (e.g. due to higher dosage, different indications), the documentation specified in Annex 6 of the Marketing Authorisation Decree should be provided.
Tab: Characteristics of medicinal products available without medical prescription
ATC code |
Active substance |
Method od administra-tion |
Maximum strenght/ |
Maximum |
Maximum |
Maximum pack size related to the content of active substance |
OTC indication |
A01AA01 |
sodium fluoride |
p.o. |
0,55 mg (eq. 0,25 mg fluorine) |
|
dep. on F content in drinking water, max. 2.2 mg |
220 mg |
Prevention of dental caries in children older than 3 years, adolescents and adults |
A01AB03 |
chlorhexidine digluconate |
orm. |
0,2 % |
|
|
600 mg |
Short-term treatment of gum (gingiva) and oral mucosa inflammation |
A02BA02 |
ranitidine |
p.o. |
75 mg |
75 mg |
225 mg |
900 mg |
Heartburn, gastric hyperacidity |
A02BA03 |
famotidine |
p.o. |
10 mg |
10 mg |
20 mg |
100 mg |
Heartburn, gastric hyperacidity |
A02BC01 |
omeprazole |
p.o. |
20 mg |
20 mg |
20 mg |
280 mg |
Gastroesophageal reflux manifested as heartburn |
A03AX13 |
simethicone |
p.o. |
42 mg, |
210 mg |
840 mg, |
4200 mg |
Excessive production and accumulation of gases in the gastrointestinal tract |
A05BA03 |
silymarin |
p.o. |
200 mg |
200 mg |
420 mg |
Supportive treatment of liver diseases |
|
A06AD11 |
lactulose |
p.o. |
66,7 g in 100 ml |
45 ml |
45 ml |
500 ml |
Constipation |
A09AA02 |
multienzyme preparations (lipase, protease etc.) |
p.o. |
40 000 units of lipase |
75 000 units of lipase |
1500-2000 un. of lipase per kg of body weight |
|
Treatment of exocrine pancreatic insufficiency (substitution of digestive enzymes) |
A11DA
|
vitamin B1 benfothiamine |
p.o. |
50 mg |
50 mg |
150 mg |
4500 mg |
Deficiency or increased need of vitamin B1 |
A11DB |
vitamin B1, combinations with vitamin B6 and/or B12 |
p.o. |
100 mg vit. B1, |
100 mg vit. B1, |
150 mg vit. B1, |
4500 mg vit. B1, |
Increased need of B-group vitamins, peripheral nervous system disorders |
A11GA
|
ascorbic acid (vitamin C) |
p.o. |
1000 mg |
1000 mg |
1000 mg |
30 g |
Treatment of vitamin C deficiency |
A11GB |
ascorbic acid (vitamin C), combinations |
p.o. |
1000 mg vitaminu C, 10 mg zinc |
1000 mg vitaminu C, 10 mg zinc |
1000 mg vitaminu C, 10 mg zinc |
30 g vitaminu C + 300 mg zinc |
Treatment of vitamin C and zinc deficiency |
A12AX |
calcium, combinations |
p.o. |
1200 mg Ca, |
1200 mg Ca, |
1200 mg Ca, |
36 g Ca, 26 400 IU vitaminu D3 |
Prevention and treatment of calcium and vitamin D deficiency, increased need of calcium and vit. D |
B01AC06 |
acetylsalicylic acid |
p.o. |
160mg
|
|
160 mg (1,2,3) |
|
Secondary prevention of myocardial infarction (1), Prevention of graft occlusion after coronary artery bypass grafting (2), Coronary angioplasty, except during the acute phase (3), Secondary prevention of transient ischemic attacks and ischemic cerebrovascular accidents, provided intracerebral haemorrhages have been ruled out (4) |
C05BX01 |
calcium-dobesylate |
p.o. |
250 mg |
250 mg |
750 mg |
|
Venous insufficiency, haemorrhoids |
C05CA |
troxerutine |
p.o. |
300 mg |
300 mg |
600 mg |
|
Venous insufficiency, haemorrhoids |
C05CA53 |
diosmin, combinations |
p.o. |
900 mg |
900 mg |
900 mg |
|
Venous insufficiency, haemorrhoids |
C05CX |
escin |
p.o. |
20 mg |
40 mg |
120 mg |
lTreatment of local swelling after injury, spinal pain syndromes, disorders of venous functions in limbs |
|
C05CX01 |
tribenoside |
p.o. |
400 mg |
400 mg |
800 mg |
Venous insufficiency, haemorrhoids |
|
D01AC01 |
clotrimazole |
drm. |
1% |
|
|
600 mg |
Dermatomycosis, vaginal candidosis, acne |
D01AC10 |
bifonazol |
drm. |
1% |
|
|
350 mg |
Dermatiomycosis |
D01AC16 |
flutrimazole |
drm. |
1% |
|
|
1 g |
Dermatomycosis |
D08AG02 |
iodinated povidone |
drm. |
10% |
|
|
|
Disinfection of intact skin and oral mucosa, hygienic disinfection of hands, minor injuries and minor burns |
D10AE01 |
benzoyl peroxide |
drm. |
10% |
|
|
5 g |
Acne |
G01AF02 |
clotrimazole |
tbl.vag. |
500 mg |
500 mg |
500 mg |
600 mg |
Vulvo-vaginal mycosis, and fungal balanitis |
G01AF05 |
econazole |
sup.vag. drm.crm. |
150 mg |
150 mg |
150 mg |
750 mg |
Vulvo-vaginal mycosis, and fungal balanitis |
G04CX02 |
Serenoa repens |
p.o. |
320 mg extract |
320 mg extract |
320 mg extract |
19,2 g extract |
Voiding difficulties in 1st and 2nd-stage of benign prostatic hyperplasia |
M01AB05 |
diclofenac |
p.o. |
25 mg |
25 mg |
75 mg |
2500 mg |
Painful posttraumatic or postoperative conditions with symptoms of oedema or inflammation, back pain, period (menstrual) pain |
M01AE01 |
ibuprofen |
p.o. |
400 mg |
400 mg |
1200 mg |
40 g |
Mild to moderate pain, e.g. headache, toothache, back pain, period (menstrual) pain, muscle and joints pain associated with flu, pain in soft tissue injuries such as bruises and sprains, fever |
M01AX05 |
glucosamine |
p.o. |
1250 mg |
1250 mg |
1250 mg |
112,5 g |
Mild to moderate symptoms of osteoarthritis of the knee and hip in patients older than 18 years of age |
M01AX25 |
chondroitin sulphate |
p.o. |
800 mg |
800 mg |
1600 mg |
72 g |
Mild to moderate symptoms of osteoarthritis of the knee and hip |
N02BA01 |
acetylsalicylic acid |
p.o. |
500 mg |
1000 mg |
4000 mg |
50 g |
Mild to moderate pain, such as headache, toothache, back pain, period (menstrual) pain, pain in muscles and joints associated with flu, fever in patients older than 15 years of age |
N02BE01 |
paracetamol |
p.o. |
1000 mg |
15mg/kg |
4000 mg |
15 g |
Mild to moderate pain, such as headache, toothache, back pain, period (menstrual) pain, pain in muscles and joints associated with flu, fever |
N06BX03 |
piracetam |
p.o. |
1200 mg; |
2400 mg
|
4800 mg |
144 g
|
Central nervous system disorders, such as cognitive disorders, mental, learning, memory, speech and concentration disorders, increased fatigue |
N06DX02 |
Ginkgo biloba |
p.o. |
40 mg/ml |
120 mg |
240 mg |
14,4 g |
Mental disorders, i.e. memory and attention disorders, and emotional lability |
R01AD01 |
beclometasone |
nas. |
50 μg/1 spray
|
100 μg (dose per one nostril) |
200 μg(doce per one nostril) |
10 mg |
Treatment and prevention of allergic rhinitis in adults over 18 years of age |
R05CB01 |
acetylcysteine |
p.o. |
600 mg |
600 mg |
600 mg |
60 g |
Mucolytic therapy in acute respiratory diseases |
R05CB06 |
ambroxol |
p.o. |
75 mg 15 mg/ml 5% sprej |
75 mg
|
120 mg |
15 g
|
Mucolytic therapy in acute respiratory diseases |
R06AB03 |
dimetinden |
p.o. |
4 mg |
4 mg |
6 mg |
80 mg |
Seasonal allergic rhinitis, urticaria, pruritus, (drug and food allergies) in adults and children over 12 years of age |
R06AE07 |
cetirizine |
p.o. |
10 mg |
10 mg |
10 mg |
|
Allergic rhinitis, chronic idiopathic urticaria |
R06AE09 |
levocetirizine |
p.o. |
5 mg |
5 mg |
5 mg |
Allergic rhinitis, chronic idiopathic urticaria |
|
R06AX13 |
loratadine |
p.o. |
10 mg |
10 mg |
10 mg |
Allergic rhinitis, chronic urticaria, chronic idiopathic urticaria, allergic conjunctivitis in adults and children over 2 years of age (weighing more than 30 kg –depending on the pharmaceutical form), |
|
V03AB21 |
potassium iodide |
p.o. |
65 mg |
130 mg |
130 mg |
1950 mg |
Prevention of damage of the thyroid gland in case of nuclear accident |
Should you have any questions, please contact the Marketing Authorisation Branch, Preclinical and Clinical Documentation Assesment (Dr. Kadeřábek - jiri.kaderabek@suklcz , Dr. Kotulková -martina.kotulkova@suklcz).
Marketing Authorisation Branch
31. 8. 2012