Category of medicinal products dispensed without medical prescription

Acting in compliance with the requirements of the Act on Pharmaceuticals, the State Institute for Drug Control defines the characteristics of medicinal products that may be supplied without a medical prescription.  

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/
concentration

Maximum
single
dose

Maximum
daily
dose

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,
69,19 mg/ml

210 mg

840 mg,
14,4 ml

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,
200 mg vit. B6,
250 mg vit. B12

100 mg vit. B1,
200 mg vit. B6,
250 mg vit. B12

150 mg vit. B1,
270 mg vit. B6,
750 mg vit. B12

4500 mg vit. B1,
8100 mg vit. B6,
22,5 mg vit. B12

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,
880 IU vitaminu D3

1200 mg Ca,
880 IU vitaminu D3

1200 mg Ca,
880 IU vitaminu D3

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)
325mg (4)

 

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.
crm.vag.

500 mg
10%

500 mg

500 mg

600 mg

Vulvo-vaginal  mycosis, and fungal balanitis

G01AF05

econazole

sup.vag. drm.crm.

150 mg
1%

150 mg

150 mg

750 mg

Vulvo-vaginal  mycosis, and fungal balanitis

G04CX02

Serenoa repens

p.o.

320 mg extract
9-11:1

320 mg extract
9-11:1

320 mg extract
9-11:1

19,2 g extract
9-11:1

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;
0,2 g/ml

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

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
(200 sprays)

Treatment and prevention of allergic rhinitis in adults over 18 years of age

R05CB01

acetylcysteine

p.o.

600 mg
20 mg/ml

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
1 mg/ml

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/ml

10 mg

10 mg

 

Allergic rhinitis, chronic idiopathic urticaria

R06AE09

levocetirizine

p.o.

5 mg
0,5 mg/ml

5 mg

5 mg

 

Allergic rhinitis, chronic idiopathic urticaria

R06AX13

loratadine

p.o.

10 mg
1 mg/ml

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@sukl_cz , Dr. Kotulková -martina.kotulkova@sukl_cz).

 

Marketing Authorisation Branch

31. 8. 2012